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Senior Quality Assurance Engineer
2 months ago
We are seeking a highly experienced Senior Quality Assurance Engineer to join our team at Olympus. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality in our products and processes.
Key Responsibilities- Lead and participate in cross-functional teams to support new product development, procurement, and manufacturing, representing the Quality Assurance discipline.
- Complete assigned Quality Assurance tasks to schedule, ensuring timely and effective delivery.
- Lead the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and Olympus Quality policies and procedures for the site.
- Train location personnel on all aspects of the Quality System and regulatory standards.
- Serve as a mentor and advisor for the Quality team to assist in developing Quality Assurance skills and capabilities.
- Apply the requirements of the Quality System to processes, products, or services for the location, leading, supporting, and guiding the manufacturing line to address quality issues and resolution using the best Quality techniques and principles.
- Develop and maintain the validation and verification strategy for new and existing products and processes, leading the development and maintenance of Master Validation Plans.
- Participate in the CAPA process as required as an assignee or project team member, monitoring product and process performance metrics and acting upon trends with minimal guidance.
- Author, collaborate, and approve Quality System documentation, including change orders, DHF, DMR, DHR, labels, and labelling, etc.
- Conduct internal, vendor, and process audits to schedule, interfacing with suppliers to resolve Quality issues.
- Develop and drive measurable Quality improvements relating to products, processes, and services.
- Bachelor's degree in an Engineering discipline or equivalent, with a Master's degree preferred.
- Minimum of 8 years related experience, preferably in the medical device industry related to process/quality engineering.
- Viewed as an expert in the quality field, with strong Quality Science skills, including demonstrated statistics application and problem-solving.
- Requires background and familiarity with U.S. FDA QSR, requirements, including ISO 9001, MDD 93/42, ISO, and the ability to educate others on related subject matter.
- Leadership experience, with a proven ability to lead and manage cross-functional teams, effectively communicate with all levels of management, and drive effective change.
- Excellent verbal and written communication skills, demonstrated by the ability to generate technical reports and make presentations to middle and upper management.
- Proven Project Management skills, with the ability to manage cross-functional teams and produce results.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization and/or guidance exists.
At Olympus, people matter – our health, our happiness, and our lives. We offer a comprehensive benefits package, including competitive salaries, annual bonuses, and a 401(k) plan with company match, as well as comprehensive medical, dental, and vision coverage, effective on start date. We also offer 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 and inclusion programs, including colleague affinity networks, on-site child daycare, café, and fitness center (limited locations). We are an equal opportunity employer and welcome applications from diverse candidates.
