Senior Quality Engineer NPI (Onsite)

• Support risk management activities by maintaining Risk Management Files conducting process FMEAs implementing risk controls and evaluating process risks throughout the product lifecycle.

• Ensure compliance with ISO 14971 requirements and contribute to Critical-to-Quality identification design risk assessments and risk management documentation.

• Develop and execute validation strategies including Installation Qualification (IQ) Measurement System Analysis (MSA) Operational Qualification (OQ) and Performance Qualification (PQ).

• Support Production Part Approval Process (PPAP) process validation test method validation and First Article Inspection activities for new product introduction projects.

• Implement inspection and validation approaches that support scalable compliant and cost-effective manufacturing processes.

• Apply statistical methods process capability analysis and quality engineering tools to strengthen process performance and support nonconformance and corrective action activities for new products.

• Collaborate with suppliers by supporting qualification strategies reviewing validation activities and providing quality input for supplier selection certification and quality agreements.

• Represent Quality Assurance during design transfer activities monitor launch quality metrics such as right-first-time performance inspection costs and product escape rates and provide post-launch quality support.

What You Need

Required

• Bachelors degree in Engineering Science or a related technical field

• Minimum 2 years of full-time work experience in Quality Assurance Quality Engineering Design Transfer Manufacturing Engineering or related functions within the medical device industry

• Minimum 2 years of full-time work experience in a regulated industry environment

Preferred

• Minimum 2 years of experience in an engineering role within the medical device industry

• ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certification

• Experience working with ISO 13485 and ISO 14971 standards

• Experience with process validation test method validation FMEA statistical analysis process capability studies and Measurement System Analysis (MSA)

• Experience applying Lean Six Sigma DMAIC methodologies to process improvement initiatives