Quality Lead Engineer (Medical Device Validation)

Key Responsibilities Lead manufacturing quality assessments, audits, and remediation. Drive FPY improvement, defect reduction, and quality metrics. Review IQ/OQ/PQ, TMV, SPC, MSA, PFMEA, and process risk activities. Manage CAPA, nonconformance, and supplier quality issues. Support FDA, ISO 13485, MDSAP, and regulatory audits. Required 8+ years of medical device manufacturing quality experience. Strong Manufacturing Quality Engineering background. Experience with Class II/ medical devices. Hands-

Role: Quality engineer / Lead/ Manager Medical Devices Manufacturing Experience Positions: 5 Openings Location: Reedsville, PA (Day 1 Onsite) Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ 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

Job Title: Quality Manager - Medical Devices Locations: Reedsville PA (Onsite) & Bothell WA (Onsite) Job Type: Fulltime Total Openings: 2 Salary: $130000 - $150000 per annum + Benefits Job Description: Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional

Job Summary: Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams. Key Responsibilities: Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.Support FDA inspections and regulatory audits.Drive quality remediation and compliance initiatives.M