Job closed
Ref: KP163-67
Job description / Role
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
Requirements
Qualifications:
• Bachelor’s Degree required in Engineering, Biotech, Life Science, or Similar
• 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)
About the Company
For over 15 years Omni International Consultants has supplied high caliber personnel to the global Construction, Aviation, Banking, Logistics, IT, Hospitality, Healthcare, Oil/Gas & Manufacturing sectors.
We specialize in recruiting the highest quality, right-fit professional and have helped many candidates find their ideal opportunity.
Our Head Office is located in Bangkok, Thailand and we have 6 liaison offices located in the UK, Australia, UAE, India (Mumbai & Delhi) and Rayong, Thailand.