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Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Sr. Engineer II, Quality is responsible for providing quality and engineering support to the Operations and Quality departments. Their primary objective is to lead the NC coordination process which will include action items within all QMS lifecycle activities. Leading investigational activities around non-conformances and CAPA’s. Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Lead in the identification and completion of CAPA activities, including CAPA investigations.

• Coach NC owners and Review NC phases

• Work with functional management to ensure NC are completed with quality and integrity in a timely manner.

• Support MRB meetings and CAPA management

• Assist or lead Nonconforming product activities, including investigations and coordination/management of MRB review and approval.

• Supports design changes, process changes and new product development through team involvement and review and approval of documentation.

• Develops and implements test method validations as assigned.

• Reviews and approves validation protocols and reports for new and existing processes and equipment.

• pFMEA development and updates.

• Supports risk management file updates.

• Establishes statistically based sampling plans for inspections, verifications, validations, etc.

• Establishes and maintains Quality Management System procedures related to areas of responsibilities.

• Ensures compliance with cGMP, QSR, ISO 13485, MDD/EU MDR, and other applicable regulations and standards.

• Collects and reports quality metrics as required.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor's degree or equivalent with 4-7 years of experience, master's degree with 3 years of experience.

• Must have bachelor's degree or higher in Engineering, or Biological Sciences discipline.

• Experience with CAPA and nonconforming product processes.

• Experience with process/test method/equipment validations.

• Strong technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).

• Knowledge of statistical sampling and analysis.

• Working knowledge of medical device regulations (including FDA QSRs, ISO13485).

• Ability to communicate effectively (both written and oral).

• Must be able to observe company policies and safety procedures at all times.

• Demonstrated ability to work cross-functionally in a team environment.

• Quality Engineering/ Quality Compliance/ Quality Assurance experience in the Medical Device or similar FDA regulated industry.

• Certified Quality Engineer preferred, but not required.