Skills Alliance
Job Title:
Director of Quality Job Type:
Permanent, Full Time An innovative medical technology company are seeking a highly experienced and detail-oriented
Director of Quality
to lead their Quality Management function in a dynamic environment. This is a critical leadership position responsible for ensuring our products and processes consistently meet the highest standards of safety, efficacy, and compliance. The ideal candidate will bring extensive experience in quality assurance, regulatory compliance, and process improvement within the medical device or life sciences industry.
Key Responsibilities
Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and other applicable regulations.
Oversee quality assurance, quality control, and document control teams to ensure alignment with company goals and regulatory requirements.
Direct all internal and external audits, ensuring timely and effective resolution of findings.
Partner with R&D, Operations, and Regulatory Affairs to integrate quality into product development and manufacturing processes.
Establish metrics and reporting systems to monitor product quality, process performance, and customer satisfaction.
Lead CAPA (Corrective and Preventive Action) initiatives, root cause analysis, and risk management processes.
Ensure timely reporting and resolution of product complaints, adverse events, and nonconformances.
Serve as the primary point of contact for regulatory agencies and notified bodies regarding quality matters.
Provide leadership, coaching, and mentorship to the quality team, fostering a culture of quality across the organization.
Qualifications
Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred).
Minimum 10 years of quality experience in the medical device, biotechnology, or related regulated industry, with at least 5 years in a leadership role.
In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, MDSAP, and related global regulatory requirements.
Demonstrated success in managing quality systems, audits, and regulatory inspections.
Strong analytical, problem-solving, and decision-making skills.
Excellent communication skills, with the ability to influence at all organizational levels.
Location:
Eden Prairie, MN Salary range:
$167,000 - $265,000
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Director of Quality Job Type:
Permanent, Full Time An innovative medical technology company are seeking a highly experienced and detail-oriented
Director of Quality
to lead their Quality Management function in a dynamic environment. This is a critical leadership position responsible for ensuring our products and processes consistently meet the highest standards of safety, efficacy, and compliance. The ideal candidate will bring extensive experience in quality assurance, regulatory compliance, and process improvement within the medical device or life sciences industry.
Key Responsibilities
Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and other applicable regulations.
Oversee quality assurance, quality control, and document control teams to ensure alignment with company goals and regulatory requirements.
Direct all internal and external audits, ensuring timely and effective resolution of findings.
Partner with R&D, Operations, and Regulatory Affairs to integrate quality into product development and manufacturing processes.
Establish metrics and reporting systems to monitor product quality, process performance, and customer satisfaction.
Lead CAPA (Corrective and Preventive Action) initiatives, root cause analysis, and risk management processes.
Ensure timely reporting and resolution of product complaints, adverse events, and nonconformances.
Serve as the primary point of contact for regulatory agencies and notified bodies regarding quality matters.
Provide leadership, coaching, and mentorship to the quality team, fostering a culture of quality across the organization.
Qualifications
Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred).
Minimum 10 years of quality experience in the medical device, biotechnology, or related regulated industry, with at least 5 years in a leadership role.
In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, MDSAP, and related global regulatory requirements.
Demonstrated success in managing quality systems, audits, and regulatory inspections.
Strong analytical, problem-solving, and decision-making skills.
Excellent communication skills, with the ability to influence at all organizational levels.
Location:
Eden Prairie, MN Salary range:
$167,000 - $265,000
#J-18808-Ljbffr