Bachelor's or Master's degree in Engineering or a Scientific field
4+ years' experience with a Bachelor's or 3+ years with a Master's
Strong knowledge of medical device operations and manufacturing
Background in product development or quality assurance
Familiarity with ISO 13485 and risk management documentation
Basic statistics knowledge with experience in statistical software (e.g., Minitab)
Experience in test method validation and fixture development
Responsibilities
Perform Quality Engineering activities for product development and cleanroom build support
Ensure compliance of NPD processes with quality systems and regulations
Update risk management and design control documentation
Develop and execute validation plans for test methods
Support design verification and commercialization across multiple sites
Collaborate with cross-functional teams in R&D, manufacturing, and marketing
Perform additional tasks as assigned by leadership
Benefits
Opportunity for professional development and career growth
Cross-functional collaboration and teamwork environment
Exposure to innovative product development processes
Engagement in compliance with leading industry standards
Dynamic and fast-paced work setting
Full Job Description
Job Description:
The Senior Quality Engineer will perform Quality Engineering activities supporting product development and ongoing cleanroom build efforts, ensuring New Product Development (NPD) processes comply with quality systems and applicable regulatory standards.
The role works cross-functionally to support design verification, process validation, and commercialization activities.
Roles & Responsibilities:
Perform Quality Engineering activities related to product development and ongoing cleanroom build support.
Ensure NPD processes comply with 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.
Perform other duties as assigned by Leadership.
Requirements:
Bachelor's degree in Engineering or Scientific field with 4+ years of experience OR Master's degree or equivalent in Engineering or Scientific field with 3+ years of experience.
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 13485Experience 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.
Strong documentation and communication skills with attention to detail.
bility to build productive working relationships across all organizational levels.
bility to manage competing priorities in a fast-paced environment.
