Senior Quality Engineer

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 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.
• Strong documentation and communication skills with attention to detail.
• Ability to build productive working relationships across all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.