OverviewThe Quality Systems Manager is responsible for the development, implementation, maintenance, and continuous improvement of the site's Quality Management System (QMS). This position ensures compliance with applicable quality standards, customer requirements, and regulatory obligations while maintaining certification to established quality standards. The Quality Systems Manager leads all quality systems activities, including internal and external audits, product certifications, document control processes, management reviews, corrective action effectiveness, and quality system reporting.
Reporting to the Site Quality Leader, this role provides leadership and direction for the organization's quality systems and compliance activities and supervises a team responsible for quality data reviews, internal auditing, certification documentation, and related administrative quality functions.
Responsibilities
- Lead the execution, maintenance, and improvement of the site's Quality Management System (QMS).
- Ensure compliance with ISO standards, customer requirements, and applicable regulatory requirements.
- Supervise and develop quality systems personnel responsible for audit execution, quality data review, certification administration, and document control activities.
- Plan, coordinate, and oversee internal audits, external registrar audits, customer audits, and follow-up corrective actions.
- Establish, maintain, and improve policies, procedures, work instructions, and other controlled documents.
- Ensure effective processes for document control, record retention, and change management.
- Partner with cross-functional managers and Quality Leader to establish quality objectives and support achievement of business goals. Coordinate management review and quality system performance reports
- Monitor corrective and preventive action (CAPA) activities to verify timely closure and effectiveness.
- Lead quality system investigations and facilitate root cause analysis and improvement initiatives.
- Ensure employee training requirements are identified, documented, assigned, and completed in accordance with established procedures.
- Champion a culture of quality, compliance, and continuous improvement throughout the organization.
Qualifications
Required:
- Bachelor's degree in Engineering, Quality, Business, or related field
- 5+ years of experience in quality systems, quality assurance, or manufacturing quality.
- Certified Quality Auditor (CQA), ISO:9001 Lead Auditor, or equivalent certification.
- Previous experience owning ISO 9001 certified management systems.
- Experience leading internal, customer, and certification audits.
- Working knowledge of quality management principles, auditing techniques, corrective action processes, and continuous improvement methodologies.
- Demonstrated leadership experience with direct reports.
- Strong analytical, organizational, communication, and project management skills.
- Proficiency with Microsoft Office and quality management software systems.
Preferred:
- Experience in a manufacturing environment.
- Experience with customer-specific quality requirements and product certification programs.
- Knowledge/experience with ISO:13485.
- Certified Manager of Quality/Organizational Excellence (CMQ/OE).
- Six Sigma or Lean Certifications.
