Overview
Director of Quality Assurance Jobs in Minneapolis, Minnesota, USA at InterShunt Technologies, Inc.
Job Title:
Director of Quality Assurance
Location:
Minneapolis, MN
Position Summary: The Director of Quality Assurance will be a key member of the leadership team, responsible for overseeing all quality assurance and supporting regulatory activities. This role requires a strategic leader with a strong background in quality management systems and medical device standards with prior experience in regulatory affairs. The Director will collaborate with cross-functional engineering and clinical teams, to ensure our products are safe, effective, and compliant with all relevant regulations.
Key Responsibilities:
Develop and implement quality assurance strategies and systems to ensure compliance with regulatory requirements and industry standards.
Support the preparation and submission of regulatory filings, including U.S. FDA, EU MDR, and other international regulatory bodies.
Lead internal and external audits, ensuring readiness and compliance with regulatory inspections.
Establish and maintain quality management systems (QMS) for a clinical stage medical device company in accordance with ISO and other relevant standards.
Monitor and analyze quality metrics to identify trends and areas for improvement.
Collaborate with R&D, manufacturing, and clinical teams to ensure quality and regulatory considerations are integrated into product development.
Provide guidance and training to staff on quality and regulatory requirements.
Stay current with changes in regulatory requirements and industry best practices, ensuring the company remains compliant.
Represent the company in interactions with regulatory agencies and industry groups.
Qualifications:
Bachelor’s degree in engineering, life sciences, or a related field (advanced degree preferred).
Minimum of 8 years of experience in quality assurance within the medical device industry.
Preferred experience with quality management systems in companies conducting product development with early feasibility and clinical stage medical devices.
The preferred candidate will also have demonstrated experience supporting regulatory affairs functions.
In-depth knowledge of U.S. FDA, EU MDR, and other international regulatory requirements.
Experience with quality management systems, including ISO 13485.
Strong leadership, communication, and interpersonal skills.
Self-starter with the ability to work independently.
Ability to work effectively in a fast-paced, dynamic startup environment.
Detail-oriented with strong analytical and problem-solving skills.
Compensation and Benefits:
Competitive salary and equity compensation.
All benefits ordinarily afforded to full-time, exempt employees of the company.
Professional development opportunities.
Collaborative and innovativework environment.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Industries:
Medical Equipment Manufacturing
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Title: Director of Quality Assurance
Company: InterShunt Technologies, Inc.
Location: Minneapolis, Minnesota, USA
Category: Quality Assurance – QA/QC, Healthcare (Medical Science)
