senior Quality control engineer
The Senior Quality Engineer is responsible for supporting new product development while ensuring design controls, supplier evaluations, validations, and requirements are met. This position focuses on supporting the product development teams from concept through production and ensuring the quality objectives are achieved. The Sr. QE shall ensure mechanical and electrical systems used in development, manufacturing and as part of medical devices are developed according to good design practices, adheres to the requirements, and follows procedures.
The Senior Quality Engineer:
– Serves as quality department team member of new product development projects. The Sr. QE will serve on projects of greater scope and complexity than other QE team members.
– Provides leadership in ensuring design control process is followed as per written procedures and documentation provides evidence of these efforts
– Coordinates and manages risk management activities including creation and maintenance of risk management files by product
– Mentors and guides engineering in assuring verification and validation testing meets statistical principles and is adequately documented and performed.
5+ years in a quality engineering role in the Medical Device field or related industry
– Deep knowledge and understanding of the standards related to medical device manufacturing, including ISO13485, 21 CFR Part 820 and ISO 14971.
– Mastery of common quality tools (i.e. Cpk/Ppk, DOE, Quality Reporting, etc.).
– Experience with sterile manufacturing and packaging
– Experience with software design and validation for medical devices
– Equipment and process validations experience.
– ISO 13485 inspections and FDA inspections experience.
– Certified Quality Engineer strongly preferred