Bachelor's in Engineering or Science & 4+ years experience or Master's in Engineering or Science & 3+ years experience
Strong preference for experience in New Product Development (NPD), Design Assurance (DA), and Quality Engineering
Proficient in medical device operations and/or manufacturing processes
Knowledge of ISO 13485 and Engineering/Quality principles
Experience in developing and maintaining risk management files
Responsibilities
Perform Quality Engineering activities for product development and cleanroom support
Ensure compliance of NPD processes with quality systems and regulatory standards
Update and maintain risk management and design control documentation
Develop and execute validations and qualification plans for test methods
Support design verification and process validations during commercialization
Collaborate with cross-functional teams including R&D and regulatory
Fulfill other duties as assigned by leadership
Benefits
Collaborative work environment with cross-functional teams
Exposure to diverse aspects of product development
Opportunity to work in a regulated medical device industry
Support for professional development and continuous learning
Engagement in innovative cleanroom build activities
Full Job Description
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.
Roles & Responsibilities:
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
Develop and execute test method validations and qualification plans
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
Other duties assigned by Leadership
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
Understanding of ISO 13485
Experience developing, updating, and maintaining technical content of risk management files
Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) is a plus
Experience in test method development including validation and/or fixture development
Solid problem-solving, organizational, analytical, and critical thinking skills
Good documentation and communication skills with attention to detail
bility to build productive working relationships and interact professionally with all organizational levels
bility to manage competing priorities in a fast-paced environment
