Senior Quality Engineer

Olympus Corporation of the Americas•Brooklyn Park, MN

3d•$93,793 - $126,621•Onsite

About The Position

Develop, maintain, and support the company Quality System regulatory requirements and business strategy. Continuously improve Quality performance related to manufacturing and metrics related to the strength of the site Quality System. Leads complex projects. Mentors Quality Engineer for best practices for the use of Quality tools and methods. Can serve as a backup to the Management Representative for the site.

Requirements

Bachelor's degree in engineering discipline or equivalent. Master's degree preferred.
Minimum of 5 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 crossfunctional 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.).

Responsibilities

Is and 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.
All other essential related duties as required.
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.