Are you a quality assurance expert with a background in the medical device industry? We are currently seeking a Quality Assurance Manager (Medical Device) in Detroit, MI, to oversee and enhance the quality processes within a leading medical device company. This pivotal role requires a detail-oriented individual who can ensure compliance with industry regulations, improve quality systems, and lead a team dedicated to producing safe, high-quality medical products. If you’re ready to take on a challenging yet rewarding leadership position, we want to hear from you!
About This Role:
The Quality Assurance Manager (Medical Device) in Detroit, MI, plays a critical role in ensuring that all products meet the highest quality standards, adhere to regulatory requirements, and exceed customer expectations. You will lead a team focused on continuous improvement, manage audits, and implement quality systems to monitor all stages of the product lifecycle.
As a key member of the leadership team, the Quality Assurance Manager will ensure that the company’s products maintain compliance with FDA regulations, ISO standards, and other industry-specific requirements, while also driving internal process improvements. If you have a strong background in quality assurance within the medical device field and are eager to contribute to the success of an industry leader, this role could be the perfect opportunity for you.
Key Responsibilities – Quality Assurance Manager (Medical Device) in Detroit, MI
Develop and Maintain Quality Systems
- Establish, maintain, and enhance quality management systems to ensure product compliance with all regulatory standards.
- Oversee the creation and maintenance of SOPs (Standard Operating Procedures) and work instructions for quality processes.
- Ensure that all internal and external audits meet regulatory compliance and internal quality standards.
Lead and Manage Quality Assurance Teams
- Supervise and mentor a team of quality assurance professionals to ensure alignment with company goals.
- Foster a culture of quality, continuous improvement, and regulatory compliance within the team.
- Provide training, support, and development opportunities for quality assurance staff.
Monitor Product Quality and Compliance
- Conduct regular inspections, product testing, and analysis to ensure product quality.
- Address and resolve quality-related issues, including non-conformance and complaints, in a timely manner.
- Review and approve batch records, CAPAs (Corrective and Preventive Actions), and deviations.
Oversee Regulatory and Industry Compliance
- Ensure compliance with FDA regulations, ISO standards, and any other relevant regulatory bodies.
- Coordinate regulatory submissions and manage inspections from regulatory authorities.
- Stay updated on changes in regulatory requirements and industry best practices.
Drive Continuous Improvement and Root Cause Analysis
- Lead root cause investigations for quality issues and develop effective corrective actions.
- Identify trends and opportunities for improvement within the manufacturing processes.
- Implement continuous improvement initiatives using tools such as Six Sigma or Lean principles.
Conduct Internal and External Audits
- Plan and execute internal audits to assess compliance with quality systems and regulatory standards.
- Manage external audits from customers or regulatory agencies and lead the response process.
- Ensure audit findings are addressed and corrective actions are effectively implemented.
Collaborate with Cross-Functional Teams
- Work closely with production, R&D, and regulatory teams to ensure quality standards are met across all departments.
- Support product development teams by providing quality input during product design and testing phases.
- Facilitate communication between departments to resolve quality-related issues and improve product quality.
Ensure Supplier Quality Management
- Evaluate and monitor the performance of suppliers to ensure they meet quality standards.
- Perform supplier audits and drive quality improvements with key suppliers.
- Maintain strong relationships with suppliers to ensure consistent delivery of high-quality materials and components.
What The Client is Looking For in You
The ideal candidate for the Quality Assurance Manager (Medical Device) role in Detroit, MI, will have a strong background in quality management within the medical device industry. Specifically, the client is looking for someone who possesses:
- Extensive Industry Experience – A solid track record in managing quality assurance within FDA-regulated environments, preferably in medical devices.
- Leadership Capabilities – Proven experience in managing and mentoring a quality assurance team while driving continuous improvement initiatives.
- Regulatory Knowledge – Deep understanding of FDA regulations, ISO standards, and other industry-specific compliance requirements.
- Problem-Solving Skills – Ability to conduct root cause analysis and implement corrective and preventive actions for quality issues.
- Attention to Detail – High level of accuracy and meticulous attention to detail when ensuring products meet the highest standards of quality and compliance.
- Communication Skills – Excellent verbal and written communication skills to effectively collaborate with cross-functional teams and external regulatory bodies.
- Technical Acumen – Familiarity with quality management software, statistical process control, and industry-specific tools for managing and improving quality systems.
Why This Opportunity Stands Out
This is a unique opportunity for a seasoned Quality Assurance Manager (Medical Device) to join a rapidly growing and highly respected medical device company in Detroit, MI. What makes this opportunity stand out:
- Career Growth – The company is expanding, which means ample opportunity for career progression and professional development.
- Industry Impact – Play a key role in ensuring the highest standards of quality and compliance, directly impacting patient safety and product efficacy.
- Leadership Influence – Work closely with senior management and cross-functional teams to drive improvements across the organization.
- Dynamic Environment – Join a collaborative and innovative work culture where your expertise in quality assurance will be valued and integral to the company’s success.
- Comprehensive Benefits Package – Competitive salary, health benefits, retirement plans, and additional perks that support both personal and professional well-being.
FAQs About the Role
Q: Is relocation required for this position?
A: The role is based in Detroit, MI. Candidates must either be local or willing to relocate. A relocation package may be available for the right candidate.
Q: What is the reporting structure for this role?
A: The Quality Assurance Manager (Medical Device) in Detroit, MI will report directly to the Director of Quality Assurance and collaborate with senior leadership and cross-functional teams.
Q: What qualifications and certifications are required for this role?
A: A bachelor’s degree in Engineering, Life Sciences, or a related field is required. Certification in quality management systems (e.g., Six Sigma, ISO 13485, or ASQ certifications) is preferred.
Q: What is the expected travel requirement for this position?
A: Some travel may be required for supplier audits, regulatory inspections, and industry conferences, but the majority of work will be based in Detroit.
Q: What kind of leadership style is expected for this role?
A: The ideal candidate should be a hands-on, results-driven leader with a focus on driving continuous improvement and fostering a collaborative team environment.
Q: What impact will this role have on the company’s success?
A: The Quality Assurance Manager (Medical Device) will have a significant impact on ensuring product quality and compliance, which are critical to maintaining the company’s reputation and success in the market.
Q: How does this role contribute to the overall company goals?
A: This role plays a central part in ensuring that products meet the highest quality standards, contributing to the company’s growth, customer satisfaction, and regulatory compliance.
Q: What is the timeline for hiring and onboarding?
A: The company is looking to fill this role as soon as possible, and the hiring process is expected to take 30-45 days. Onboarding will include training on internal processes and quality systems.
What Remuneration Can You Expect from This Job?
As the Quality Assurance Manager (Medical Device) in Detroit, MI, you can expect a competitive compensation package that reflects your expertise and the critical nature of the role. The base salary for this position typically ranges from $95,000 to $125,000 per year, depending on experience and qualifications.
In addition to the base salary, the role offers performance-based bonuses and incentives tied to key quality milestones and company objectives. You may also be eligible for stock options or other long-term incentives, depending on the company’s policies.
The benefits package is comprehensive, including medical, dental, and vision coverage, life insurance, and a 401(k) retirement plan with company matching contributions. Paid time off (PTO), sick days, and holidays are also included, along with opportunities for professional development and training.
As part of the company’s commitment to employee well-being, you will have access to a range of work-life balance programs and wellness initiatives. The company values your contributions and strives to provide a rewarding compensation package to support your personal and professional goals.
How to Apply for This Quality Assurance Manager (Medical Device) Position in Detroit, MI
If you are a detail-oriented, regulatory-focused professional with experience in quality assurance within the medical device industry, we encourage you to apply for the Quality Assurance Manager (Medical Device) role in Detroit, MI. This is an excellent opportunity to contribute to a leading company that is committed to maintaining high-quality standards in its medical device manufacturing.
To apply, please submit your resume along with a cover letter that outlines your relevant experience in quality assurance, FDA regulations, and medical device compliance. Highlight your leadership abilities and experience with quality management systems.
This role offers a unique chance to make a significant impact on the company’s quality standards while contributing to the success of medical device products that improve patient outcomes. Apply today to take the next step in your career!
For more information or to explore similar opportunities, visit our Medical Device Recruiters page.
Tags: Quality Assurance Manager | Medical Device Quality Assurance | FDA Compliance | ISO 13485 | Regulatory Compliance | Quality Systems Management
