Quality Assurance Manager

Barrington James • Contract • Minnesota, United States, US • 18h ago

We are seeking a highly skilled and experienced Quality Manager to lead the quality assurance and regulatory compliance efforts within our medical device organization. The ideal candidate will ensure that our products meet all applicable regulatory requirements, quality standards, and customer expectations. This role is critical in driving continuous improvement, ensuring product safety, and maintaining our commitment to excellence in healthcare innovation.

Key Responsibilities:

Quality Management System (QMS): Oversee the development, implementation, and maintenance of the QMS to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulations.
Regulatory Compliance: Ensure all products and processes comply with relevant industry regulations, including FDA, EU MDR, and other international standards. Stay updated on regulatory changes and ensure company practices align with current guidelines.
Audits and Inspections: Lead internal and external audits, including regulatory inspections, to ensure readiness and adherence to quality standards. Address any findings and implement corrective actions as needed.
Risk Management: Develop and maintain risk management processes according to ISO 14971, identifying potential product risks and implementing mitigation strategies.
Continuous Improvement: Lead initiatives to improve product quality, manufacturing processes, and operational efficiency. Use root cause analysis, CAPA processes, and other quality tools to resolve quality issues.
Supplier Quality Management: Manage supplier qualification, audits, and performance evaluations to ensure that materials and components meet quality standards. Address any supplier-related issues in a timely manner.
Document Control: Ensure proper documentation of quality procedures, policies, records, and reports in compliance with regulatory requirements. Oversee changes to controlled documents and ensure accuracy.
Training and Development: Train and mentor staff on quality management systems, regulatory requirements, and best practices. Foster a culture of quality awareness and continuous improvement throughout the organization.
Cross-functional Collaboration: Work closely with engineering, production, regulatory, and customer service teams to address quality issues and ensure successful product launches.
Complaint Handling and Post-Market Surveillance: Oversee the investigation of customer complaints, non-conformances, and other post-market quality issues. Ensure timely reporting to regulatory bodies when necessary.

Qualifications:

Bachelor’s degree in engineering, quality management, or a related field (advanced degree preferred).
Minimum of 5-7 years of experience in quality management, preferably in the medical device industry.
Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable standards.
Experience with quality tools such as Six Sigma, Lean, and root cause analysis.
Proven track record of managing audits and regulatory inspections.
Excellent problem-solving skills and attention to detail.
Strong leadership and communication skills with the ability to collaborate across departments.
Certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) are a plus.

Contract Details: