Quality Engineering Senior

The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment.

The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams.

Perform Quality Engineering activities related to product development and ongoing cleanroom build support

Ensure NPD processes comply with the quality system and applicable regulatory standards

Update risk management and design control files and maintain relevant quality documentation

Support design verification and facilitate process validation and commercialization activities related to multi-site transfer

Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing

Job Summary The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment.

The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams.

Perform Quality Engineering activities related to product development and ongoing cleanroom build support

Ensure NPD processes comply with the quality system and applicable regulatory standards

Update risk management and design control files and maintain relevant quality documentation

Support design verification and facilitate process validation and commercialization activities related to multi-site transfer

Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing

The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment.

The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams.

Perform Quality Engineering activities related to product development and ongoing cleanroom build support

Ensure NPD processes comply with the quality system and applicable regulatory standards

Update risk management and design control files and maintain relevant quality documentation

Support design verification and facilitate process validation and commercialization activities related to multi-site transfer

Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing

Education & Experience Bachelor's degree in Engineering or Scientific field & 4+ years' experience OR Master's degree or equivalent in Engineering or Scientific field & 3+ years' experience

Strong preference for candidates with experience in NPD, Design Assurance (DA), and Quality Engineering

Proficient understanding of medical device operations and/or manufacturing processes; medical device experience strongly preferred

Relevant experience in product development, quality assurance, and/or related fields

Knowledge and understanding of Engineering and Quality principles, theories, and concepts

Experience developing, updating, and maintaining technical content of risk management files

experience using statistical software (e.g.,