Quality engineer

Role: Quality engineer

Location: Reedsville, PA (Day 1 Onsite)

Experience: 8+ Year

Duration: 12+ Months

Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/III medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments.

Key Responsibilities:

• Manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction initiatives.
• Review process validation (IQ/OQ/PQ) and risk management activities.
• Manage CAPA, nonconformance, and supplier quality issues.
• Support FDA, ISO 13485, MDSAP, and regulatory audits

Required Skills:

• Manufacturing Quality Engineering.
• Process Validation and TMV.
• Must hace design control experience
• SPC, MSA, and PFMEA.
• CAPA and Nonconformance Management.
• Minimum 4+ years of Medical Device Manufacturing Quality experience.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971

Disclaimer: Diverse Lynx LLC is an Equal Opportunity Employer. All applicants and employees are evaluated without discrimination, based solely on their qualifications, ability, competence and performance. This email and its attachments may contain confidential or proprietary information and is intended only for the recipient(s). If you received this message in error, please disregard it and notify the sender. If you no longer wish to receive our communications, you may unsubscribe at any time.

Security Notice: Our official website is www.diverselynx.com We do not operate or authorize any other websites representing Diverse Lynx LLC.