Quality Manager | Pittsfield, MA

Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.

Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.

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.