We are seeking a skilled Quality Assurance Professional to join our dynamic Receiving Inspection team. This onsite role offers the chance to work at the forefront of innovation, supporting the development and validation of inspection processes, fixtures, and quality systems aligned with industry standards.
Key Responsibilities
1. Lead the evaluation and implementation of inspection methods and sampling plans for high-volume and complex components.
2. Collaborate cross-functionally with R&D, Supplier Quality, and Operations Engineering to drive robust inspection processes.
3. Design, develop, and qualify custom inspection fixtures and measurement equipment.
4. Conduct Gage R&R studies and measurement system analyses to ensure repeatability and accuracy.
5. Develop and validate test methods in compliance with industry standards and regulatory requirements.
6. Investigate and resolve Out-of-Spec (OOS) events and drive root cause analysis and CAPA activities.
7. Support the training and supervision of lab personnel in inspection techniques and quality standards.
8. Manage documentation including Change Orders and Non-Conformance Material Reports (NCMRs), ensuring traceability and audit readiness.
Required Skills and Qualifications
Bachelor's or Master's degree in Engineering or a related technical discipline is required. 5+ years of quality engineering experience within the medical device, biotech, or pharmaceutical sectors is also required. Strong experience in inspection methods, fixture design, and measurement systems analysis (including Gage R&R) is necessary. Proficient in CAD software and statistical analysis tools is preferred.
Benefits
This role is ideal for someone with a proactive mindset, strong problem-solving skills, and a passion for improving human health through high-quality engineering solutions.