Vice President of Quality Assurance (Med Device) in Phoenix, AZ

Are you a quality-driven executive with extensive experience in medical device manufacturing? We are seeking a Vice President of Quality Assurance (Med Device) in Phoenix, AZ to lead and enhance the company’s quality assurance programs, ensuring compliance with FDA regulations, ISO standards, and global regulatory requirements. This role requires a strategic leader with a deep understanding of quality systems, risk management, and continuous improvement methodologies. If you have a passion for maintaining the highest standards in product quality and regulatory compliance while driving innovation, this is an excellent opportunity to make a significant impact in a growing medical device company.

About This Role

As the Vice President of Quality Assurance (Med Device) in Phoenix, AZ, you will be responsible for overseeing all aspects of quality assurance, quality control, and regulatory compliance within the organization. This includes developing and implementing quality management systems, ensuring adherence to FDA, ISO, and international regulatory requirements, and fostering a culture of continuous improvement. You will work closely with cross-functional teams, including manufacturing, regulatory affairs, and R&D, to enhance product safety, reliability, and compliance. The ideal candidate will have strong leadership skills, the ability to manage large quality teams, and a proactive approach to risk mitigation and quality excellence.

Key Responsibilities – Vice President of Quality Assurance (Med Device) in Phoenix, AZ

Develop and Oversee Quality Management Systems (QMS)

Implement and maintain a robust QMS aligned with FDA, ISO 13485, and other global regulatory requirements.
Ensure continuous improvement of QMS processes to enhance efficiency and compliance.
Conduct internal audits and management reviews to identify areas for enhancement.

Ensure Regulatory Compliance and Audit Readiness

Lead company-wide efforts to maintain compliance with FDA, ISO, and international medical device regulations.
Prepare for and manage external audits, including FDA inspections, ISO certifications, and notified body assessments.
Collaborate with regulatory affairs to ensure product approvals meet all necessary quality and compliance standards.

Drive Continuous Improvement Initiatives

Develop and implement quality improvement programs focused on defect reduction and process efficiency.
Utilize Lean, Six Sigma, and other quality methodologies to drive operational excellence.
Monitor key quality metrics and implement corrective and preventive actions (CAPAs) as needed.

Lead Risk Management and Mitigation Strategies

Establish risk assessment protocols, including Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).
Work with engineering and manufacturing teams to identify and mitigate product and process risks.
Ensure timely resolution of quality issues and non-conformances to minimize regulatory and business risks.

Oversee Supplier Quality Management

Develop and manage supplier qualification, auditing, and performance monitoring programs.
Collaborate with procurement and supply chain teams to ensure supplier adherence to quality standards.
Implement supplier corrective action programs to improve product quality and reliability.

Enhance Product Quality and Customer Satisfaction

Lead initiatives to ensure product safety, reliability, and performance meet or exceed customer expectations.
Analyze customer complaints and feedback to drive quality improvements and enhance brand reputation.
Develop training programs to strengthen quality awareness across the organization.

Manage and Develop Quality Assurance Teams

Build and mentor a high-performing quality assurance and quality control team.
Provide leadership, training, and professional development to ensure team members stay updated on industry best practices.
Foster a culture of accountability, collaboration, and continuous learning within the QA department.

Collaborate with Cross-Functional Teams

Work closely with R&D, manufacturing, and regulatory affairs to align quality strategies with business goals.
Provide quality input during new product development to ensure compliance from concept to commercialization.
Develop quality-related training and education programs for employees at all levels.

What The Client is Looking For in You

To succeed as the Vice President of Quality Assurance (Med Device) in Phoenix, AZ, you need a combination of technical expertise, strategic leadership, and a results-driven mindset. The ideal candidate will possess:

Extensive Quality Assurance Leadership Experience – At least 10+ years of progressive leadership experience in quality assurance within the medical device industry, including oversight of quality systems, compliance, and risk management.
In-Depth Knowledge of Regulatory Standards – A thorough understanding of FDA regulations (21 CFR Part 820), ISO 13485, MDR, and other global regulatory requirements impacting medical devices.
Proven Success in Compliance & Audit Management – A track record of successfully leading FDA inspections, ISO audits, and global regulatory compliance initiatives, ensuring company-wide adherence to quality standards.
Strong Risk Management & Problem-Solving Skills – Expertise in identifying, assessing, and mitigating quality and compliance risks using tools such as FMEA and CAPA.
Continuous Improvement & Lean Manufacturing Experience – Familiarity with Six Sigma, Lean, and other process improvement methodologies to drive operational excellence.
Supplier Quality & Manufacturing Oversight – Experience managing supplier quality programs, conducting supplier audits, and ensuring supply chain compliance with medical device quality standards.
Leadership & Team Development – Ability to build, mentor, and lead high-performing quality assurance and regulatory teams while fostering a culture of accountability and innovation.
Cross-Functional Collaboration – Strong interpersonal skills to effectively work with engineering, regulatory, manufacturing, and executive teams to align quality strategies with business goals.
Passion for Quality & Patient Safety – A commitment to maintaining the highest product quality and safety standards, ensuring patient well-being and regulatory success.

Why This Opportunity Stands Out

As the Vice President of Quality Assurance (Med Device) in Phoenix, AZ, you will be in a pivotal role shaping the quality strategy of a growing medical device company. Here’s why this opportunity is exceptional:

Be a Key Decision-Maker in a Growing Organization – You will have the opportunity to lead the quality assurance function at a company poised for growth, directly influencing product quality and regulatory success.
Work with Cutting-Edge Medical Technologies – Be part of a company that is developing innovative medical devices that improve patient outcomes and redefine industry standards.
Lead Global Regulatory Compliance Initiatives – Take charge of global regulatory compliance efforts, ensuring that products meet FDA, ISO 13485, MDR, and international standards.
Opportunity for Career Advancement – This executive role positions you as a strategic leader with potential for growth into higher-level corporate leadership positions.
Competitive Compensation & Benefits Package – Enjoy an attractive salary, performance-based incentives, comprehensive healthcare benefits, and executive perks.
Collaborate with High-Performing Teams – Work alongside top professionals in engineering, manufacturing, and regulatory affairs to drive quality and compliance excellence.
Make a Meaningful Impact on Patient Safety – Your work will directly contribute to ensuring the safety, efficacy, and quality of medical devices used by healthcare professionals and patients worldwide.
Exposure to Global Markets & Regulations – Work with international teams and suppliers, gaining experience in global medical device quality standards and compliance requirements.

This role is a rare opportunity to lead, innovate, and elevate quality assurance within an industry-leading medical device company.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have extensive experience in medical device quality assurance, compliance, and regulatory management. Familiarity with FDA, ISO 13485, MDR, and other global medical device regulations is essential.

Q: Is relocation required for this position?
A: The role is based in Phoenix, AZ. Candidates must either be local or willing to relocate. A relocation package may be available for qualified candidates.

Q: What is the reporting structure for this role?
A: The Vice President of Quality Assurance (Med Device) in Phoenix, AZ will report directly to the Chief Operating Officer (COO) and work closely with executive leadership teams.

Q: What kind of leadership style is expected?
A: The ideal candidate should be a proactive, hands-on, and strategic leader who can balance compliance, risk management, and operational efficiency while fostering a culture of continuous improvement.

Q: What is the expected travel requirement?
A: This role may require occasional travel to manufacturing sites, supplier facilities, and regulatory meetings, both domestically and internationally.

Q: What qualifications and skills are required?
A: Candidates should have a bachelor’s or master’s degree in quality management, engineering, regulatory affairs, or a related field. A minimum of 10+ years of leadership experience in medical device quality assurance is required. Six Sigma or Lean certification is a plus.

Q: How does this role contribute to the company’s success?
A: The Vice President of Quality Assurance (Med Device) in Phoenix, AZ plays a crucial role in ensuring product safety, regulatory compliance, and quality excellence, directly impacting company growth and reputation.

Q: What is the timeline for hiring and onboarding?
A: The company aims to fill this role within the next 60–90 days. Onboarding will include an in-depth review of current quality systems, compliance strategies, and collaboration with cross-functional teams.

This role is ideal for a quality-focused leader who thrives in regulatory environments and is passionate about driving excellence in medical device manufacturing.

What Remuneration Can You Expect from This Job?

As the Vice President of Quality Assurance (Med Device) in Phoenix, AZ, you can expect a highly competitive compensation package reflective of your expertise, leadership, and ability to drive quality excellence in the medical device industry. The base salary for this executive role typically ranges from $180,000 to $250,000 per year, depending on experience, industry knowledge, and regulatory expertise.

In addition to the base salary, this role offers a performance-based bonus structure tied to key quality and compliance metrics, including successful regulatory audits, quality system improvements, and overall risk mitigation. The total annual compensation, including incentives, can exceed $300,000 for top-performing executives.

Other executive benefits include:

Equity or stock options (depending on company structure and performance metrics).
Comprehensive health, dental, and vision insurance for you and your family.
401(k) with company matching to support your long-term financial goals.
Executive travel benefits for regulatory meetings, supplier audits, and industry conferences.
Relocation assistance for qualified candidates willing to move to Phoenix, AZ.
Professional development opportunities, including leadership training and industry certifications.

This role offers not only financial rewards but also career growth, strategic influence, and the chance to shape quality assurance at a leading medical device company.

How to Apply for This Vice President of Quality Assurance (Med Device) Position in Phoenix, AZ

If you are a quality-driven leader with a proven track record in medical device quality assurance, regulatory compliance, and process improvement, we invite you to apply for the Vice President of Quality Assurance (Med Device) in Phoenix, AZ. This is an exceptional opportunity to lead global quality strategies, ensure regulatory excellence, and make a meaningful impact in the medical device industry.

To apply, please submit your resume and a cover letter detailing your experience in quality management, regulatory compliance, and medical device manufacturing.

This executive role provides an exciting chance to shape the future of quality assurance while working alongside top industry professionals. Apply today to take the next step in your career as a Vice President of Quality Assurance (Med Device) in Phoenix, AZ!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Tags:

Job Category: Vice President of Quality Assurance

Job Type: Full Time

Job Location: Phoenix