We have an immediate need for a Senior Design Quality Engineer who will be the subject matter expert for design controls and quality engineering for a successful global diagnostics manufacturer. This organization is on the cutting edge of technology as it relates to diagnosing diseases (imaging, laboratory, molecular medicine) and digital health/enterprise offerings.

Key elements to this position:

• Be a Subject Matter Expert; providing expertise across design control for new product development (commercial diagnostics hardware & software); leading QMS (Quality Management System) improvement projects and training efforts
• Lead effective tools, development, transfer, and maintenance of complex systems throughout the entire product lifecycle
• Utilize Lean & Six Sigma methodologies across the business
• Drive quality engineering principals & problem-solving skills/methodologies, risk analysis, statistical techniques
• Ensure regulatory requirements are adhered to; guiding/recommending new plans if needed (CFR 21 Part 820, EU IVDD, IVDR, ISO 13485, etc.) Be a SME during regulatory inspections.
• Lead risk management, design verification, process/design validation activities for products and processes
• Provide supplier quality audit support; implementing design control elements as needed
• Partner with cross functional teams to ensure test methods are appropriate
• Lead investigations into quality issues and CAPAs

Qualifications:

• Bachelor’s Degree required (Engineering, Biotech, Life Science, or Similar)
• Min 5+ years experience in NPD design quality & control with IVD, laboratory diagnostics, or similar products of regulated nature. Will be a subject matter expert so needs to be able to speak to driving design control success across hardware/software systems working in a matrixed environment with cross functional teams
• Experience leading Quality Management System improvement projects and training efforts
• Ability to work independently and in project teams.
• Excellent communication skills (written and spoken)