Senior Quality Engineer

About the role

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.

Job Duties

• Leads 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.
• Affords assistance to others to lead and develop novel approaches within the Quality team.
• 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.
• Maintains 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.
• Serves as a liaison to 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.
• Supports Verification/Validation/Calibration/Preventive maintenance activities.
• Communicates significant issues or developments identified during Quality assurance activities and provides recommended process improvements to cross-functional teams (CFTs) and management.
• Runs reports to analyze Production and Complaint data and identify any significant trends.
• Supports the Quality Management System (QMS) by performing periodic product process and internal audits.
• Performs other duties as needed.

  Job Qualifications

  • 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 cross- functional teams effectively communicate with all levels of management and drive effective change.
  • 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.
  • Prominent 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.).

  Benefits

  Competitive salaries, annual bonus and 401(k)* with company match
  Comprehensive medical, dental, vision coverage effective on start date
  Employee Assistance Program
  Free live and on-demand Wellbeing Programs
  Generous Paid Vacation and Sick Time
  Paid Parental Leave and Adoption Assistance*
  12 Paid Holidays
  On-Site Child Daycare, Café, Fitness Center**
  Paid volunteering and charitable donation/match programs
  Employee Resource Groups
  Dedicated Training Resources and Learning & Development Programs
  Paid Educational Assistance

  Pay

  The anticipated base pay range for this full-time position in this location is $100,263.00 - $135,355.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

  Schedule

  Hybrid