Quality Assurance Manager

Key Responsibilities

Quality Leadership & Management Responsibility

• Lead, maintain, and continuously improve the site Quality Management System in alignment with company objectives, applicable regulations, customer requirements, and recognized medical device quality standards.
• Lead site QA and QMS compliance, ensuring quality requirements are integrated into operational, technical, and business decisions.
• Establish annual quality objectives, performance indicators, improvement priorities, and department goals; regularly communicate progress, risks, and resource needs to site leadership.
• Plan and facilitate management review activities, including preparation of quality data, identification of trends, documentation of decisions, and follow-through on assigned actions.
• Lead and develop assigned QA personnel; partner with, but do not manage, the separately led QC/Inspection function.
• Preserve QA authority to hold product, stop processes, prevent shipment, or escalate risks, while holding process owners accountable.
• Promote accountability, timely escalation, right-first-time records, consistent standards across shifts, improvement, and patient safety.

Quality Management System & Regulatory Compliance

• Ensure the site Quality Management System complies with ISO 13485 , the FDA Quality Management System Regulation (QMSR) under 21 CFR Part 820, applicable customer requirements, and other regulatory or certification requirements relevant to the products and markets supported by the facility.
• Write and improve practical, controlled procedures, work instructions, forms, specifications, and quality records; verify they are followed.
• Drive Good Documentation Practices on the floor, reviewing manufacturing and inspection records and correcting recurring paperwork errors.
• Verify approved drawing revisions and changes are fully implemented in job packs, manufacturing programs, inspection plans, and floor practices before manufacture.
• Verify NPD and intercompany-transfer readiness, including quality requirements, validation evidence, customer approvals, and documented release criteria.
• Verify employee competence and application of standards across shifts through observation and record review, not just completed training records.
• Maintain awareness of changing regulatory, certification, and customer requirements and coordinate timely updates to the Quality Management System.

Audit, Inspection & Certification Readiness

• Maintain risk-based internal audits that test actual floor practices, records, process controls, and corrective-action effectiveness across shifts.
• Lead preparation for and execution of FDA inspections, ISO certification audits, customer audits, supplier audits, and other external assessments.
• Serve as a primary site contact during quality-system audits and inspections, coordinate requested records and subject-matter experts, and ensure responses are accurate, timely, and supported by objective evidence.
• Lead audit-finding investigation, corrective action, owner accountability, effectiveness verification, and sustainable closure.
• Maintain audit readiness through usable procedures, accurate records, competence checks, validation evidence, and shop-floor reviews.
• Escalate significant compliance concerns, repeated systemic failures, or potential reportable events to the appropriate site, corporate, regulatory, or legal leadership without delay.

CAPA, Nonconformance, Complaints & Risk Management

• Personally lead nonconformance and CAPA investigations, confirm root causes, hold action owners to deadlines, and verify actions prevent recurrence.
• Ensure nonconforming product is documented, controlled, and dispositioned by authorized personnel; coordinate containment with QC and Operations.
• Chair or support Material Review Board activities, ensuring approved dispositions, rework, concessions, and release decisions are justified and documented.
• Support complaint investigations, returned-product evaluations, field-action assessments, and regulatory-reporting evaluations by providing timely manufacturing, inspection, and quality-system information.
• Apply risk-based judgment to deviations, documentation gaps, changes, suppliers, new-product introductions, transfers, and validations.
• Analyze recurring defects, paperwork errors, escapes, complaints, audits, and deviations; require process owners to address root causes.
• Confirm temporary containment stays in place until permanent corrective action is verified effective.

Production Quality Assurance, Validation & QC Coordination

• Verify on the floor that manufacturing and inspection follow approved controls. QC/Inspection owns inspectors, CMM programming, measurement, priorities, backlogs, and shift coverage.
• Verify inspection plans, sampling, acceptance criteria, alerts, and records are controlled and followed; QC owns the execution of inspections.
• Partner with Operations, Engineering, and QC on product and process issues; Operations and Engineering own their work, while QA challenges and verifies controls.
• Verify quality requirements and validation evidence for manufacturing processes, equipment, software, cleaning, packaging, NPD, and intercompany transfers.
• Verify measuring-equipment controls, including calibration status, suitability, records, and escalation of suspect equipment, in coordination with QC.
• Review measurement-system risks, gauge studies, inspection-method controls, and process capability with QC and Engineering, without managing CMM programming.
• Verify quality records and release criteria are complete and only trained, authorized personnel approve product release or shipment.

Supplier Quality & Customer Support

• Establish and maintain supplier quality controls, including qualification, monitoring, performance review, supplier corrective actions, risk-based audits, and approval status.
• Partner with Supply Chain and Engineering to evaluate supplier changes, quality issues, special processes, outsourced activities, and incoming material risks.
• Ensure supplier nonconformances and recurring performance concerns are addressed through effective containment, investigation, corrective action, and follow-up.
• Serve as a quality contact for customers regarding audits, quality agreements, corrective actions, scorecards, product concerns, documentation requests, and improvement activities.
• Provide accurate and timely quality information to customers while protecting confidential information and ensuring commitments are reviewed and approved by the appropriate stakeholders.
• Support customer-specific quality planning, inspection, documentation, traceability, and change-notification requirements.

Quality Metrics, Continuous Improvement & Cross-Functional Collaboration:

• Track QA metrics including documentation accuracy, repeat nonconformances, CAPA timeliness and effectiveness, audits, complaints, supplier quality, change control, and competence.
• Use trends, floor observations, and risk data to identify weaknesses, assign process owners, and confirm improvements are sustained.
• Participate in production reviews, changes, NPD, intercompany transfers, and planning to verify quality controls before execution.
• Work with QC, Operations, Engineering, Maintenance, Supply Chain, HR, and Finance on solutions while maintaining QA independence.
• Report quality risks, product holds, investigation progress, change readiness, CAPA commitments, and closure evidence promptly.
• Manage assigned QA resources, priorities, services, and improvements; coordinate with, but do not manage, QC/Inspection resources.
• Perform other quality, compliance, and leadership responsibilities as assigned by site or corporate management.

Qualifications & Requirements

Required

• Bachelor’s degree in quality, engineering, manufacturing, life sciences, business, or a related field; an equivalent combination of education and directly relevant experience may be considered.
• Seven or more years of progressive quality experience in regulated manufacturing, including at least three years of quality leadership or people-management responsibility.
• Demonstrated working knowledge of ISO 13485 , FDA medical device quality-system requirements, Good Documentation Practices, change control, CAPA, nonconformance control, auditing, and management review.
• Experience leading external audits or regulatory inspections and preparing written responses, corrective action plans, and objective evidence for closure.
• Understand precision manufacturing, drawing revisions, job packs, GD&T, inspection plans, traceability, and shop-floor controls.
• Hands-on experience reviewing records, investigating root causes, writing procedures, implementing CAPA, and verifying effectiveness.
• Able to challenge process owners, enforce accountability, lead through influence, and remain independent of inspection execution.
• Strong written and verbal communication skills, including the ability to communicate effectively with employees, senior leadership, auditors, regulators, customers, and suppliers.
• Proficiency with Microsoft Office and experience using electronic quality, ERP, document-control, training, calibration, or manufacturing systems.
• Able to work onsite and regularly visit the manufacturing floor, wear required PPE, and verify practices across shifts.

Preferred

• Experience in medical device manufacturing, orthopedic implants, surgical instruments, precision machining, aerospace, or another highly regulated industry.
• Advanced degree in quality, engineering, regulatory affairs, operations, or business administration.
• ASQ Certified Manager of Quality/Organizational Excellence, Certified Quality Engineer, Certified Quality Auditor, or similar professional certification.
• Certified ISO 13485 lead auditor or substantial experience leading ISO 13485 internal and external audits.
• Experience with FDA inspections, QMSR implementation, MDSAP, EU medical device requirements, customer quality agreements, or international regulatory expectations.
• Experience with process validation, software validation, risk management, statistical methods, Lean manufacturing, Six Sigma, and measurement-system analysis.
• Experience managing quality for CNC machining, passivation, cleaning, packaging, special processes, or outsourced manufacturing operations.

Soft Skills

• High level of integrity, objectivity, confidentiality, and commitment to patient safety and product quality.
• A hands-on leader who reviews records, investigates problems, coaches colleagues, and personally follows actions through.
• Highly organized, with the ability to manage investigations, changes, audits, projects, and corrective-action deadlines.
• Analytical and risk-focused, with the ability to distinguish isolated errors from systemic quality concerns.
• Collaborative and solutions-oriented while protecting QA independence and separate QC/Inspection responsibilities.
• Clear, respectful, and persuasive communicator who can translate technical and regulatory requirements into practical expectations.
• Practical, visible, hands-on improvement mindset with strong follow-through on the manufacturing floor.

Why Join HG Medical?

• Competitive compensation and comprehensive benefits .
• A key leadership role within an expanding medical device manufacturing facility , with the opportunity to shape the Quality Management System, develop a strong team, and directly influence product quality and patient safety.