Location: Westborough, MA
Company: Olympus
lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View We deliver on our purpose and our core values by staying True to Life. Job Description Provide Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company.
Represents Quality as a team member to support new product development procurement manufacturing returns and servicing of products produced. Can serve a backup as the Management Representative for the location. Job Duties Cross-Functional Team member to support new product development procurement manufacturing and
servicing processes representing Quality Engineering discipline. Completes assigned Quality Engineering tasks to schedule. Promotes awareness of Quality and Regulatory requirements.
Leads or participates in the development of process and procedure development/changes. Applies statistical process control (SPC) methods to evaluate current processes and process changes. Develops new approaches to solve problems identified as part of the team. Assist in the implementation compliance and maintenance of standards (e. g. FDAISO13485) and OGA Quality policies and procedures. Trains location personnel on all aspects of the Quality System and regulatory standards. Serves as a mentor for the Quality
team to assist in developing Quality Engineering skills. Applies the requirements of the Quality System to processes products or services for the location.
Supports the manufacturing line to address quality issues and resolution. Provides support to metrology and preventive maintenance programs. Supports validation and verification strategy for new and existing products and processes as assigned. Leads the development and maintenance of Master Validation Plans. Participates in the CAPA process as required as an assignee or project team member. lnvestigates escalated product complaints to root cause to ensure timely customer response and correction. Monitors product and process performance metrics and acts upon trends (positive or negative).
Leads MRB as a team member to ensure proper disposition of non- conformances. Authors collaborates and approves Quality System documentation including change orders DHF DMR DHR labels and labelling etc. Conducts internal vendor and process audits to schedule. o Interfaces with suppliers to resolve Quality issues. Develops and drives measurable Quality improvements relating to products processes and services. All other essential related duties as required Job Qualifications Required: Bachelor's degree in Engineering discipline or equivalent.
Minimum of 8 year's related experience and/or training; preferably in the medical device industry related to process/quality engineering. Leadership experience (Le. People and Administrative Skills); ability to lead and manage cross-functional teams. Knowledge of basic mechanical testing and material properties. Knowledge of metrology. Requires background and familiarity with U. S. FDA QSR requirements including ISO 9001 MDD 93/42 ISO 13485-2003 and Canadian Medical Device requirements. Working knowledge of Problem Solving Tools (i. e. Process Mapping Histograms FMEA Risk backssment Cause & Effect Diagrams PDCA Pareto Analysis etc.
) Working knowledge of Quality Tools (i. e. Quality Planning Quality Costs and backssment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles and AQL TOM Lean Six Sigma etc. ) Proven Project Management skills. Proficient in the use of Information Technology and applications. Preferred: ASQ certifications in one or more of the following areas is preferred but not required: Certified Quality Engineer (COE) or Certified Quality Auditor (CQA).
Working knowledge of problem solving skills - good statistical and analytical skills. Good verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management. #LI-Onsite Why join Olympus? Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k) with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center US Only Limited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
Learn more about our benefit offerings at /careers/benefits-perks. About us: Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
For more information, visit . Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive. Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: United States (US) Massachusetts (US-MA) Westborough Quality & Regulatory Affairs (QA/RA)
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