Senior Supplier Quality Engineer

Job Description :

Pay Range: $44.70hr - $49.70hr

• The Supplier Quality Engineer II is responsible for ensuring supplier compliance with federal, state, local, and company regulations while supporting supplier quality systems and supplied product requirements.
• This role focuses on supplier qualification, validation, risk management, inspection development, and non-conformance resolution within a highly regulated industry environment.

• Bachelor s degree in Engineering or Scientific field.
• Minimum 2+ years of experience in supplier quality, manufacturing, or quality engineering functions.
• Experience in a highly regulated industry (medical device, pharma, biotech, or similar).
• Knowledge of supplier qualification and validation processes.
• Experience supporting risk management and validation activities.
• Ability to manage multiple projects and changing priorities.
• Strong communication and organizational skills.

• Ensure compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Work with suppliers to ensure quality system and product requirements are clearly understood and met.
• Help define supplier qualification requirements for OEM and custom materials/devices.
• Ensure validation methods for critical suppliers and incoming quality control align with device risk, internal standards, global regulations, and industry best practices.
• Support Design Development File requirements related to supplied components, subassemblies, devices, and services.
• Support supplier risk management and validation activities.
• Develop inspection methods and procedures for receiving inspection and/or supplier final release.
• Execute test method validation activities.
• Assess non-conformances and lead closure of Supplier Corrective Action Requests (SCARs).
• Support Client and CAPA processes as needed.

• Engineering degree.
• Experience conducting supplier/vendor audits.
• Experience with Class II and Class III medical devices.
• Knowledge of FDA and international regulatory standards for medical devices.
• Proficiency in Design Controls, risk management, and test method validation.
• Experience with root cause analysis, dFMEA, Gage R&R, and other statistical/quality tools.
• Demonstrated ability to conduct root cause investigations and corrective action assessments (NCRs/SCARs).
• Ability to read and interpret engineering drawings.
• Six Sigma XX Belt and/or LEAN Manufacturing experience.
• ASQ Certified Quality Engineer (CQE) or ASQ/BSI Certified Quality Auditor preferred.
• Strong time management and ability to work independently with minimal supervision.

• Strong analytical and problem-solving skills.
• Effective communication and conflict resolution abilities.
• Highly organized with strong documentation skills.
• Ability to collaborate effectively with external suppliers.
• Results-driven mindset with attention to detail.