Quality Engineer I (Operations)

• Supports test method validation, PFMEA, and inspection activities to ensure product quality and process reliability.

• Collaborates with cross-functional teams to drive risk analysis, compliance, and continuous improvement.

• Develops and maintains quality documentation, including procedures, work instructions, and inspection methods.

• Generates and analyzes reports (e.g., FAI) to support product compliance and manufacturing readiness.

• Trains personnel on quality processes to ensure consistent adherence to requirements.

• Reviews and investigates product issues and/or customer complaints or other nonconformities, including quality system assessments, root cause determinations, and recommends corrective and preventive actions where required.

• Provides quality support for products and project development.

• Acts as a quality representative for quality issues in transfer products.

• Conduct routine walkthroughs (Gemba) in manufacturing areas to identify opportunities for improvement.

• Provide feedback to manufacturing engineering to reduce rejects and non-conforming materials.

• Ensure that documentation and processes comply with GMPs, GDPs, and applicable regulatory requirements.

• Formulate, analyze, and present statistical data reports on registrations and tests developed by your CFT.

• Provide support and assistance in manufacturing process validations at your CFT.

• Perform inspections and/or tests of products, raw materials, equipment, or accessories according to established specifications using special test equipment, including, where necessary, the development of test equipment specifications and protocols.

• Participate in your CFT's mandatory meetings, Tier 2 meetings, and weekly meetings.

• Execute and comply with the specific activities and requirements outlined in the documented quality system.

• Know and apply the policies and procedures of Quality Systems, ISO 13485, and any other system required by the company for its operations.