Senior Quality Engineer

Workplace Flexibility:
Onsite

• Participates in Cross-functional teams to support manufacturing representing Quality Engineering discipline.
• Completes assigned Quality Engineering tasks to schedule.
• Leads or participates in the development of process and procedure/development changes.
• Provides resident expertise in the application of Quality Sciences including statistics, data analysis, problem solving and the creation of system solutions.
• Develops, maintains and reviews product risk management files, and provides guidance on application of risk management to Quality System processes (FMEAs, NCR risk, CAPA risk, etc.).
• Develops new approaches to solve problems identified as part of the team.
• Assists others to lead and develop novel approaches within the Quality team.
• Leads the implementation, compliance, and maintenance of standards (e.g., FDA CFR Title 21 §820, ISO 13485, ISO 14971) and Olympus Global Quality policies and procedures for the sites.
• Trains location personnel on all aspects of the Quality System and regulatory standards.
• Serves as a mentor and advisor for the Quality team to assist in developing Quality Engineering skills and capabilities.
• Applies the requirements of the Quality System to processes, products, or services for the location.
• Leads, supports, and guides the manufacturing line to address quality issues and resolution using the best Quality techniques and principles.
• Develops and maintains the validation and verification strategy for new and existing products and processes.
• Leads Quality system elements such as but not limited to:
  Validation, Deviation, Data Trending, CAPA, Audits etc.
• Leads and participates in the CAPA process as required as a CAPA Owner or Coordinator.
• Monitors product and process performance metrics and acts upon trends with minimal guidance.
• Authors, collaborates, and approves Quality System documentation including change orders for DHF, DMR, DHR, labels and labelling etc.
• Support Supplier Quality Engineering to resolve Quality issues, providing information to and interfacing with suppliers as required.
• Develops and drives measurable Quality improvements relating to products, process, and services.
• Support Verification/Validation/Calibration/Preventive maintenance activities.
• Communicate significant issues or developments identified during Quality assurance activities and provide recommended process improvements to cross‑functional teams (CFTs) and management.
• Run reports to analyze Production and Complaint data and identify any significant trends.
• Support the Quality Management System (QMS) by performing periodic product process and internal audits.
• Perform other duties as needed.

Required:

• Bachelor's degree in engineering discipline or equivalent. Master's degree preferred.
• 5 plus years related experience preferably in the medical device industry related to process/quality engineering.
• Viewed as an expert in the quality field. Leadership experience: proven ability to lead and manage cross‑functional teams effectively communicate with all levels of management and drive effective change.
• Requires background and familiarity with regulatory requirements and international standards, including U.S. FDA QSR requirements, EU MDR 2017/745, Canada Medical Device requirements, ISO 13485:2016, and ISO 14971:2019, and the ability to educate others on related subject matter.
• Strong Quality Science skills including demonstrated statistics application and problem solving.
• Excellent verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management.
• Proven Project Management skills with ability to manage cross functional team 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.
• Working knowledge of problem‑solving tools and root cause analysis techniques (i.e., FMEA, Pareto Analysis, Cause & Effect diagrams, 5‑whys, Ishikawa diagrams, etc.)

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)
* with company match

24/7 Employee…