Quality Control Manager | Brockton, MA

partnership with the Glaukos's external operations team, supply chain and Regulatory Affairs groups, and will be the interface internally with these teams as well as with the Quality groups at the CMOs/Distributors, as it relates to all quality assurance matters.

Ensures Glaukos products and procedures applicable to this scope are in compliance with all applicable worldwide product registration, distribution/economic operator, serialization, and quality system requirements. Participates with cross-functional teams to ensure manufacturing and distributing activities are properly completed on schedule ensuring compliance with ISO 13485, EU-MDR, and 21CFR 4, 210, 211, 820 and any other applicable

regulations. What will you do? General Quality Management Responsible for: ensuring that Glaukos quality system requirements are effectively established and maintained in accordance with quality system regulations and reporting to Sr.

Management on the performance of the quality system elements specific to manufacturing, post-market distributing activities. Activities include oversee CMO and world-wide distributors processes. Advises on areas of compliance risk and recommends appropriate corrective and preventive actions. Implements policies when selecting methods, techniques, and evaluation criteria for obtaining results. Works on issues where analysis of situations or data requires

an in-depth knowledge of organizational objectives. CMO Support Activities Oversee quality applicable aspects of components, drug substances, manufacturing, labeling and packaging, finished goods release and distribution performed by suppliers/vendors for all Glaukos products including medicals, medical devices, and combination products.

Sustain and optimize procedures for the oversight of all contracted and subcontracted services performed by a CMO for Glaukos. Ensure current and accurate Quality Agreements are in place and trained on by impacted Glaukos staff for CMOs. Drives, leads, and troubleshoots quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.

Serves as Glaukos Quality Person in Plant for CMO(s) Ensures contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections. Post-Market Responsible for partnering with CMOs and Distributors to investigate product complaints in accordance with established procedures. Perform trend analysis on a routine basis and review for any patterns. Ensure prompt escalation and complete documentation for any high-risk complaint or trend.

Support Medical Safety with Vigilance, MDRs, and other regulatory reporting activities. Lead the Post - Production Risk backssment process. Assist with FDA and other compliance audits including corporate audits. Supplier/Distribution Quality Management Collaborate with Operations, Supply Chain, Business System Group and EHS functions on development & execution of distribution management strategy. Monitor distribution performance and distribution quality to ensure desired levels of performance and prompt escalation of identified trends/concerns. Creation of distributors economic training, on-boarding new distributors.

Established and maintained procedures for the oversight of distribution quality management activities associated with Glaukos products. Oversee distribution quality management activities for distributors. Oversight to include confirmation of compliance, management of quality audits, support necessary Regulation filings/reporting, inspection readiness activities, and appropriate resolution of corrective and preventive action plans, as required. Develops, implements, and manages a distribution management system appropriate for the activities of Glaukos.

Leadership Promotes within the organization the understanding of the Quality System Regulations and the benefits of achieving high standards of compliance. Ensure all behaviors are aligned with the positive Glaukos culture of product and process excellence, high integrity and demonstrated commitment to excellence in communication, collaboration, customer focus, and courage to do the right thing throughout the organization Develops, implements, and communicates the quality strategy, policies and programs How will you get here? Bachelor's Degree in a scientific, quality, or regulatory discipline with 8+ years industry experience; or 6+ years with a Master's Degree; or 4+ years with a Ph D.

Knowledge, Skills, and Abilities Current, in-depth knowledge of FDA, European Union and other international regulatory, quality and clinical requirements pertaining to medical devices and medicals used in ophthalmic surgery. Experience with internal and vendor auditing. Experience with facility, process, and product validations. Excellent analytical skills (interpret data, summarize data, present data). Excellent written and verbal communication skills with demonstrated success communicating with various health authorities around the world.

Motivated and able to work independently, as well as within a team. Exhibits personal integrity, credibility, and responsibility. Excellent organizational skills and ability to work on multiple projects/tasks. Meets milestones, budgets, and schedules. Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family. Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide.

And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class!

Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years! Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction including interactionual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

ABOUT US Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and medical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device-the i Stent®-in the United States, followed by our next-generation i Stent inject® device in September 2018 and i Stent inject® W in September 2020.

In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and medical therapies for glaucoma, corneal health, and retinal diseases. Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol " GKOS" Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, interaction including interactionual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.

assigned to. Engages with customers and vendors on performance, quality, and compliance issues. Directly supervises and coaches a team of QA Inspectors, QA Technicians, and QA Engineers to support the business. Coaches and guides other operations team members to help PRIMARY DUTIES AND RESPONSIBILITIES Proactively gathers and analyzes relevant data using standard CI tools to get to the root cause and actions needed to prevent reoccurrence.

Generates innovative ideas to solve problems and drives teams to close all actions and monitor effectiveness In leadership role proactively intervenes, coaches and guides Pelican teams to adjust processes and supports improvement to change course Champions

problem solving throughout the business operations through coaching and teaching to ensure proper follow up and root cause analysis is performed. Ensures there is a culture of developing, training against and following standards within the operation through training, auditing, and holding teams accountable Ensures critical product and equipment qualification is handled correctly and documented appropriately according to the company standard.

Develops and provides adequate training on Pelican’s Quality Management Systems and ensures there is consistent awareness of quality expectations and employee awareness through regular training and education. Leads/ Drives continuous improvement activities

in the operation related to mistake proofing and quality system improvements through the development of current and future state process maps, Kaizen events and continuous improvement plans.

Oversees and maintains the ISO9001 Pelican Quality Management Systems and is the main contact for the registrars and customers requiring confirmation to the standard. In coordination with the Purchasing Department, establishes and champions a supplier evaluation system to ensure supplier quality. Assists vendors in establishing inspection standards to meet the organization’s quality requirements. Monitors customer complaints, returns and defects. Conducts root cause analysis and recommends modifications in products, services, or quality standards where applicable.

Reviews analysis with the leadership team and facilitates activities to address systemic root causes. Performs and oversees the completion of internal quality audits. Leads quality gemba walks with the quality, engineering, maintenance and operations teams regularly. Communicates with customers and suppliers, when necessary, and travels to the sites as required. Acts as the main contact of the plant for Pelican’s Product Liability Process (PLP) and liaises with the Vice President of Worldwide Quality and Operations Management to ensure the process is adhered to.

Part of the New Product Design process to ensure new products continually improve their performance in the field. Part of the contract review process and translates them into relevant requirements in order to meet expectations. Oversees compliance with government and defense contractor requirements. Maintains knowledge of regulations and communicate changes effectively. Follows company policies and practices as outlined in the Employee Handbook and/or applicable employment agreement. Follows safety guidelines and procedures in accordance to the job.

Performs additional duties as assigned. JOB REQUIREMENTS Education: Bachelor’s Degree in Quality or Engineering, and/or equivalent 5+ years related experience in a manufacturing or plastic injection molding environment Actively participates as an operations leader – ownership, proactive and course correcting Must have excellent verbal, written, math and presentation skills. Ability to delegate work to and motivate, lead, train, and evaluate staff. Ability to work under minimal supervision. Demonstrated proficiency in problem solving methods/ tools and root cause analysis Must be trained as an ISO9001 Internal Auditor by a recognized body.

Proficient with word processing, spreadsheet, and flow-charting software and ERP systems. Ability to use measuring tools including calipers, micrometers, inside/outside micrometers, Vernier, pin gauges, height gauges, radius gauges, protractors, and dial indicators. ADDITIONAL INFORMATION: Actively supports and complies with Pelican’s objectives, guidelines and commitment to Quality and Safety, with an emphasis on continual improvement. Must be able to interact effectively and cooperatively with employees at all levels.

Must have the ability to complete assignments within the timeframe specified by the Manager. Must be flexible regarding working hours. Must be able to work evenings and weekends, with or without advanced notice. Must be able to operate in a fast-paced environment and handle multiple projects simultaneously. Ensures that staff is contributing at maximum potential through rigorous hiring practices and an emphasis on training and development initiatives, including coaching and counseling direct reports in their performance and professional development, with final authority for approving pay increases, hiring decisions and disciplinary actions.

Emphasizes ethical leadership and decision-making to protect Pelican’s brand and reputation. Establishes challenging, productive and achievable goals for direct reports; measure results by establishing checkpoints to track progress. Must be able to travel, nationally and internationally, as necessary. Must have the ability to complete assignments within time frame specified by the Vice President of Worldwide Quality. PHYSICAL REQUIREMENTS AND WORKING CONDITIONS While performing the duties of this job, the employee will be constantly required to execute standard physical activities within the facility areas (i.

e. stand, walk, sit, use hands/fingers). While performing the duties of this job, the employee will be frequently required to execute non-standard physical activities within the facility areas (i. e. climb or balance, stoop, kneel, crouch). Ability to lift and/or move up to 35 pounds and occasionally lift and/or move up to 40 pounds. This position requires repetitive hand/wrist activities. Pelican Products, Inc. is an Equal Employment Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction including interactionual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

where you belong and can be the best version of yourself. If you're passionate about achieving goals, trying new things and making an impact every day, we want to hear from you! Position Summary: We're looking for an experienced Operational Quality Leader as a Director of Corporate Quality to join our team with the focus of working with internal and external manufacturing locations to ensure our products are safe, consistently delight consumers, and fully comply with all regulatory and food safety expectations.

Where You'll Work: This role should be located in one of the following locations: Concord, MA (Boston, MA area) North East, PA (Erie, PA area) Lawton, MI (Kalamazoo, MI area) What

You'll Do: Provide direct leadership to operational quality team, including strategic planning, project management, issue resolution, and day to day operations.

Lead and drive the development and implementation of food safety & quality policies and procedures necessary to assure product safety, quality and regulatory standards are met. Assist with development and implementation of programs to assure needed step change in behavior and create true quality culture. Provide technical support and troubleshooting for food safety and quality at manufacturing sites (owned, contract, licensed) to ensure the highest quality and safest food reaches our consumers and customers. Develop and foster

interactions with R&D scientists, engineering, and manufacturing partners to provide guidance on food safety and quality programs to assure appropriately designed processes, product, and equipment.

Conduct audits of food processing and storage facilities to backss compliance to company and regulatory standards. Deliver clearly written audit reports that establish action plans and verify follow up. Coach and develop FSQ Operations Team members. Lead and drive the development and implementation of food safety & quality policies and procedures necessary to assure product safety, quality and regulatory standards are met. Assist with development and implementation of programs to assure needed step change in behavior and create true quality culture.

Provide leadership and guidance for CQV (commissioning / qualification / verification) process for new production lines, new products, new processes. Who You Are: An experienced food safety & quality leader who can effectively work and influence in both a manufacturing plant and corporate environment A proactive collaborator who plans and executes projects, gaining alignment and support across functions to deliver against strategic goals and day to day issue management. A results-driven individual committed to delivering business impactful solutions.

Strong practical risk backssment skills with an ability to work under pressure A strong team player who can work well in a dynamic environment and maintains a level of flexibility to support the broader team and deliver business results. A person who is passionate about delivering consistent, high-quality products to our consumers and customers that are safe and fully comply with all regulations. Engages in healthy dialogue and makes decisions with Welch's best interest in mind. What You'll Need: 8 - 10 years combined experience in Corporate Food Safety or Quality Assurance, Plant Quality Assurance, and Plant Operations with demonstrated expertise managing food safety and quality initiatives in Food/Beverage Industry B.

S. required and preferred in Food Science, Engineering, Chemistry or Microbiology Working knowledge of HACCP, FSMA, statistical process control, GMPs, CIP, sanitary design, and total quality management principles or techniques Ability to travel 25% to 30% travel (project based, primarily domestic) What You'll Enjoy: Organization with a bold, clear purpose. Authentic culture that supports working together to deliver results.

Workplace where teams care about each other and your voice is heard. Core and voluntary benefits so you can choose the right recipe for you. Generous 401(k) plan with annual company match. Flexible schedules so you can balance your work life priorities. Learning and development opportunities with coaching. Safe and clean working environment. Welch's is an Equal Employment Opportunity Employer: Minority/Female/Disability/Protected Veteran Job Posted by Applicant Pro

Atlantic Ocean, to stealth bombers, to landing on the moon. We look for people who have bold new ideas, courage and a pioneering spirit to join forces to invent the future, and have fun along the way. Our culture thrives on intellectual curiosity, cognitive diversity and bringing your whole self to work - and we have an insatiable drive to do what others think is impossible.

Our employees are not only part of history, they're making history. Climb to new heights on your journey when you start Defining Possible with Northrop Grumman. Enjoy a purposeful career in aeronautics that is crucial to the way we connect and protect our world across land, sea, and air. Bring your experience and

take advantage of this opportunity to discover how you can start to push past possible and achieve your goals today. Enjoy a diverse, collaborative environment with professionals across the nation ready to help launch your career.

Our Aeronautics Systems sector is seeking a Production Test Technician 3 to join our team of qualified, diverse individuals. This position will support our RF Microwave team and will be located in Hopkinton, MA. What you'll get to do: Set up test apparatus and conduct tests of production assemblies and units following methods, procedures, standards, and sequences. Assemble units for production according to designs and specifications. Adjust and calibrate systems

as needed. Make adjustments by tuning or replacing parts or components as needed.

Use hand and small power tools, and various measuring and testing devices in performing job duties. May monitor and verify quality in accordance with statistical process or other control procedures. Basic Qualifications: High School diploma or equivalent (GED) with 4 years additional education and/or related experience in Microwave RF Ability to operate an RF anechoic chamber Ability to obtain and maintain a DOD Secret level clearance, including Special Program Access within a reasonable period, as defined by the company to meet its business needs. Clearance is not required to start nor to apply Do D applies US Citizen Preferred Qualifications: Knowledge of high-power broad band antenna and passive microwave components and a strong aptitude and interest in working with automated and manual test equipment Familiarity with using Network and Spectrum Analyzers, Power Meters, Oscilloscopes, RF Sources and other equipment used in the testing of microwave components Proven performance of microwave electronics testing and recording and maintaining test data Good communication and interpersonal skills, working in a team environment Ability to follow both verbal and written instructions Good hand-eye coordination for work under a microscope Working knowledge of Microsoft Office Salary Range: $57,800 - $96,300The above salary range represents a general guideline; however, Northrop Grumman considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions.

Employees may be eligible for a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results.

Employees in Vice President or Director positions may be eligible for Long Term Incentives. In addition, Northrop Grumman provides a variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business. Northrop Grumman is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, interaction, interactionual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.

For our complete EEO/AA and Pay Transparency statement, please visit http: ///EEO. U. S. Citizenship is required for most positions. PDN-9adbc64b-8ea3-4e7c-9e24-1c3e0611709a