Are you an experienced quality assurance leader with a passion for ensuring the highest standards in medical device manufacturing? We are seeking a Director of Quality Assurance (Medical Device) in Salt Lake City, UT, to drive compliance, implement quality systems, and lead regulatory initiatives. This executive role is crucial for maintaining product integrity, meeting FDA and ISO standards, and ensuring patient safety through effective quality management.
As the Director of Quality Assurance (Medical Device) in Salt Lake City, UT, you will oversee quality control processes, regulatory compliance, and risk management strategies while leading a high-performing team. If you have a strong background in FDA regulations, ISO 13485, CAPA processes, and medical device quality assurance, this is an opportunity to make a significant impact in a growing and innovative healthcare company.
About This Role
The Director of Quality Assurance (Medical Device) in Salt Lake City, UT will play a pivotal role in defining and implementing quality assurance strategies that ensure compliance with regulatory requirements and industry standards. This position requires a strategic leader who can develop, monitor, and enhance quality management systems (QMS) to maintain product safety, efficacy, and compliance.
From overseeing supplier quality management to ensuring FDA audit readiness, the Director of Quality Assurance (Medical Device) in Salt Lake City, UT, will be responsible for quality across all stages of product development and manufacturing. If you excel in process improvement, risk assessment, and team leadership within the medical device sector, this is an outstanding opportunity to contribute to the success of an industry-leading organization.
Key Responsibilities – Director of Quality Assurance (Medical Device) in Salt Lake City, UT
1. Develop and Implement Quality Assurance Strategies
- Establish and maintain a comprehensive Quality Management System (QMS) aligned with FDA, ISO 13485, and other global regulatory standards.
- Drive a culture of quality excellence by integrating best practices into daily operations.
- Develop policies and procedures that ensure continuous improvement in quality performance.
2. Oversee Regulatory Compliance and FDA Readiness
- Ensure full compliance with FDA, ISO 13485, MDR, and other regulatory requirements governing medical devices.
- Lead preparation for FDA inspections, ISO audits, and third-party regulatory reviews.
- Stay ahead of regulatory changes, ensuring company policies and procedures remain up to date.
3. Lead CAPA, Non-Conformance, and Risk Management Processes
- Implement Corrective and Preventive Action (CAPA) programs to address product and process deficiencies.
- Investigate non-conformance reports, root causes, and implement corrective actions.
- Utilize risk management frameworks to proactively identify and mitigate quality-related risks.
4. Ensure Supplier Quality and Vendor Compliance
- Develop and manage supplier quality assurance programs to ensure compliance with regulatory and company standards.
- Conduct supplier audits, quality assessments, and performance reviews.
- Collaborate with suppliers to improve raw material and component quality.
5. Oversee Internal and External Audits
- Plan and execute internal audits to assess compliance with company policies and regulatory standards.
- Work with third-party auditors and regulatory bodies to ensure successful external audits.
- Address audit findings with root cause analysis and corrective action plans.
6. Lead Product Quality Testing and Validation
- Oversee product testing, validation, and verification throughout the development and manufacturing process.
- Ensure that all medical devices meet performance, safety, and compliance standards before release.
- Work with engineering and R&D teams to validate new product designs and manufacturing processes.
7. Drive Continuous Process Improvement in Quality Systems
- Utilize Lean Six Sigma and other methodologies to enhance efficiency and reduce defects.
- Monitor key performance indicators (KPIs) to identify areas for quality improvement.
- Foster a culture of operational excellence by promoting innovation in quality processes.
8. Lead and Develop the Quality Assurance Team
- Recruit, train, and mentor a team of quality professionals, engineers, and auditors.
- Establish clear performance goals and provide ongoing feedback to ensure team success.
- Foster collaboration between quality, manufacturing, regulatory, and R&D teams to drive quality excellence.
What The Client is Looking For in You
To excel as the Director of Quality Assurance (Medical Device) in Salt Lake City, UT, you should bring a combination of technical expertise, regulatory knowledge, and leadership skills. The ideal candidate will possess:
- Extensive Experience in Medical Device Quality Assurance – A proven track record in FDA-regulated environments, with in-depth knowledge of ISO 13485, MDR, and other global medical device regulations.
- Regulatory and Compliance Mastery – Strong experience in FDA audits, ISO certifications, CAPA processes, and risk management strategies.
- Strategic and Process-Driven Leadership – Ability to develop and implement quality systems and continuous improvement programs that drive operational excellence.
- Supplier and Manufacturing Quality Expertise – Knowledge of supplier audits, vendor compliance, and quality control processes to maintain product integrity.
- Strong Analytical and Problem-Solving Skills – A data-driven approach to root cause analysis, non-conformance resolution, and risk mitigation.
- Team Leadership and Development – Proven ability to build, mentor, and lead high-performing quality assurance teams while fostering a culture of quality excellence.
- Excellent Communication and Cross-Functional Collaboration – Ability to work effectively with R&D, manufacturing, regulatory affairs, and senior leadership teams.
- Passion for Innovation and Continuous Improvement – A proactive mindset in adopting new technologies, process optimization, and regulatory best practices to ensure compliance and efficiency.
Why This Opportunity Stands Out
This role offers a unique opportunity to be at the forefront of quality assurance leadership in the medical device industry. As the Director of Quality Assurance (Medical Device) in Salt Lake City, UT, you will:
- Shape the Future of Medical Device Quality – Lead quality initiatives that directly impact patient safety and product reliability.
- Work in a High-Growth Environment – Join an innovative company with a strong pipeline of medical device products poised for market expansion.
- Competitive Compensation & Benefits – Enjoy an attractive salary package, performance-based bonuses, and executive-level benefits.
- Direct Influence on Regulatory Compliance – Play a pivotal role in FDA readiness, ISO certifications, and global compliance strategies.
- Collaborate with Industry Leaders – Work alongside top professionals in engineering, manufacturing, and regulatory affairs to drive quality excellence.
- Professional Growth & Development – Benefit from opportunities for career advancement, leadership training, and exposure to cutting-edge technologies.
- Make a Meaningful Impact in Healthcare – Ensure the delivery of high-quality, safe, and effective medical devices that improve patient lives worldwide.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in the medical device industry, specifically in quality assurance, regulatory compliance, and risk management. Experience in FDA-regulated manufacturing is required.
Q: Is relocation required for this position?
A: The role is based in Salt Lake City, UT. Candidates must either reside in the area or be open to relocation. A relocation package may be available for the right candidate.
Q: What is the reporting structure for this role?
A: The Director of Quality Assurance (Medical Device) in Salt Lake City, UT will report directly to the Vice President of Quality & Regulatory Affairs and collaborate closely with manufacturing, engineering, and compliance teams.
Q: What qualifications and certifications are required?
A: A bachelor’s or master’s degree in engineering, quality management, life sciences, or a related field is required. Additional certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma Black Belt are highly preferred.
Q: What are the key regulatory requirements for this role?
A: Candidates must have in-depth knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and CAPA processes.
Q: What kind of leadership style is expected?
A: We are looking for a collaborative, proactive, and results-driven leader who can mentor teams, improve processes, and ensure compliance with industry regulations.
Q: How does this role contribute to the company’s success?
A: The Director of Quality Assurance (Medical Device) in Salt Lake City, UT will ensure that all medical device products meet the highest quality and regulatory standards, directly impacting market approvals, patient safety, and overall business growth.
Q: What is the expected hiring timeline?
A: The company is actively seeking the right candidate and aims to complete the hiring process within 60–90 days. The onboarding process will include strategy meetings, quality system evaluations, and compliance training.
What Remuneration Can You Expect From This Job?
As the Director of Quality Assurance (Medical Device) in Salt Lake City, UT, you can expect a highly competitive compensation package designed to attract top industry talent. The base salary for this executive role typically ranges between $140,000 and $180,000 per year, depending on your experience, expertise, and track record in medical device quality assurance.
In addition to a strong base salary, the company offers performance-based bonuses, which can significantly increase your total earnings. Bonuses are typically tied to quality metrics, regulatory compliance achievements, and successful audit outcomes.
The benefits package includes comprehensive health, dental, and vision insurance, ensuring you and your family receive top-tier medical care. Additionally, the company provides 401(k) matching, paid time off (PTO), and professional development opportunities, allowing you to invest in your career growth.
For candidates relocating to Salt Lake City, UT, the company may offer a relocation assistance package, covering moving expenses and temporary housing. Executives in this role may also be eligible for stock options, profit-sharing plans, and leadership development programs, ensuring long-term career advancement and financial growth.
If you are looking for a well-compensated leadership position in a thriving medical device company, this opportunity offers both financial rewards and professional fulfillment.
How to Apply for This Director of Quality Assurance (Medical Device) Position in Salt Lake City, UT
If you are an experienced quality assurance leader with a strong background in medical device manufacturing, regulatory compliance, and quality management systems, we encourage you to apply for the Director of Quality Assurance (Medical Device) in Salt Lake City, UT. This is an excellent opportunity to lead quality assurance initiatives, ensure compliance with global regulatory standards, and drive continuous improvement in a fast-paced medical device company.
To apply, please submit your resume and a cover letter detailing your experience in quality assurance leadership, regulatory compliance, ISO and FDA standards, and risk management within the medical device industry.
This role offers a high-impact leadership opportunity to shape quality processes, implement compliance strategies, and work with cross-functional teams to ensure product excellence. Apply today to take the next step in your career as a Director of Quality Assurance (Medical Device) in Salt Lake City, UT!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Quality Assurance | Medical Device Quality | Regulatory Compliance | ISO 13485 | FDA Compliance | Quality Management Systems | Risk Management
