Quality Engineer

Quality Engineer Job Title: Quality Engineer Employment Type: Full-Time Schedule / Shift: Monday – Friday, 8:00 AM – 5:00 PM Location / Work Setting: On-site Position Overview We are seeking a Quality Engineer to execute standard quality engineering assignments as a vital component of ongoing and new project initiatives. In this role, you will apply sound technical problem-solving techniques, assess product and process conformance, and collaborate cross-functionally to ensure strict adherence to medical device quality standards and regulatory compliance. Key Responsibilities & Essential Functions Quality Engineering & Continuous Improvement Utilize standard quality engineering tools to solve technical problems of moderate scope (e.g., FMEA, SPC, DOE). Analyze complex production and quality trend data to identify issues and drive root-cause resolutions. Implement design, process, and material changes to enhance overall product quality, reliability, and manufacturing efficiency. Recommend material and process specifications; assess operational results for validity and conformance. Validation & Risk Management Execute equipment and process qualifications and validations using IQ, OQ, and PQ methodologies. Perform Test Method Validations (TMV) and Gauge R&R studies. Support Risk Management and risk assessment activities (including HHE, ISO 14971 compliance). Collaborate with the Calibration department to develop gauging, review/approve calibration requirements, and investigate Out-of-Tolerance (OOT) events. Compliance, Audits & Quality Systems (QMS) Ensure continuous compliance with FDA QSR, ISO, EN, AATB, and applicable international regulations. Provide investigational QA support for Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and customer complaints. Support post-market quality operations, including complaint trending, CAPAs, and Field Corrective Actions (FCAs). Facilitate document control, engineering change orders (ECOs), and design control deliverables across the product lifecycle. Participate in external regulatory inspections (e.g., FDA inspections, ISO certification/surveillance audits) and customer audits. Cross-Functional & Supplier Quality Support Support New Product Introductions (NPI) to ensure smooth, quality-compliant transitions into full-scale production. Interface directly with suppliers to review specifications, resolve supplier quality issues, and issue Supplier Corrective Action Requests (SCARs). Participate in supplier qualification and conduct internal and supplier audits. Lead small project teams as needed to accomplish target objectives. Qualifications Minimum Qualifications Education: Bachelor’s Degree in Engineering, Life Sciences, or a related technical discipline. Technical Skills: Strong technical aptitude with proven ability to analyze data and resolve engineering problems of moderate complexity. Communication: Strong verbal and written communication skills; comfortable presenting findings and drafting technical documentation. Work Style: Ability to prioritize and multitask effectively in a fast-paced manufacturing environment. Preferred Qualifications Industry Experience: 1+ years of experience in the medical device, tissue banking, or regulated life sciences industry (an equivalent combination of an advanced degree and relevant experience will also be considered). Certifications: ASQ Certification (e.g., CQE, CQA, Six Sigma Green/Black Belt) is a plus. Regulatory Familiarity: Practical knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, 21 CFR Part 1271, and/or AATB standards. Physical Demands & Environmental Conditions In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions. Physical Movement: Frequent or continuous standing, walking, bending, stooping, kneeling, crouching, and repetitive hand/wrist/finger motions or grasping. Lifting & Handling: Frequent or continuous moderate lifting (15–40 lbs), pushing, and pulling. Work Environment: Frequent or continuous exposure to cleanroom or manufacturing plant conditions, which may include airborne irritants (dust, fumes, odors) and routine handling of chemicals/solvents with appropriate PPE.