Are you a skilled and experienced professional in the medical device industry with a strong background in quality control? We are looking for a Quality Control Manager (Med Device) in St. Louis, MO, to lead our quality assurance efforts and ensure our products meet the highest standards of safety and performance. In this key leadership role, you will play a pivotal part in driving quality improvements, managing audits, and overseeing product inspections, ensuring compliance with both internal and regulatory standards.
As the Quality Control Manager (Med Device) in St. Louis, MO, you will be responsible for overseeing the development and execution of quality control systems, managing quality audits, and coordinating with cross-functional teams to resolve quality-related issues. You will ensure that products meet the regulatory requirements and are delivered to the market in line with the company’s commitment to quality and excellence. This position demands a leader with a keen eye for detail and strong experience in the medical device industry, especially in quality control processes.
About This Role
The Quality Control Manager (Med Device) in St. Louis, MO will be instrumental in upholding the high standards of quality expected within the medical device sector. This role involves overseeing day-to-day quality control activities, developing policies and procedures for quality assurance, and working closely with production teams to ensure compliance with industry regulations. You will be expected to lead internal and external audits, manage risk assessments, and provide leadership to a team dedicated to maintaining the highest product quality. If you are passionate about quality control and have a proven record in the medical device industry, this is the ideal role for you to make a tangible impact.
Key Responsibilities – Quality Control Manager (Med Device) in St. Louis, MO
1. Oversee Quality Control Operations
- Manage all aspects of the company’s quality control operations, ensuring product conformity.
- Supervise the daily activities of the quality control team and provide guidance.
- Ensure quality processes are followed in the manufacturing of medical devices.
2. Develop and Implement Quality Control Systems
- Create and implement quality control policies and systems to improve product reliability.
- Monitor quality control metrics and initiate corrective actions when necessary.
- Ensure the quality systems meet regulatory requirements (FDA, ISO 13485).
3. Lead Audits and Inspections
- Oversee internal and external quality audits to ensure compliance with regulatory standards.
- Coordinate and prepare for FDA and other regulatory body inspections.
- Review audit findings and take appropriate actions to correct any non-compliance.
4. Manage Corrective and Preventative Actions (CAPA)
- Lead efforts in identifying root causes of quality issues and develop CAPA solutions.
- Ensure that CAPA systems are in place and track effectiveness of implemented actions.
- Work cross-functionally with teams to implement process improvements.
5. Conduct Risk Management and Product Validation
- Lead risk management activities, including failure mode effects analysis (FMEA).
- Conduct validation activities for new products and processes.
- Ensure that all risk management activities comply with regulatory guidelines.
6. Monitor Supplier Quality
- Establish and maintain strong relationships with suppliers to ensure product quality.
- Monitor and evaluate supplier quality and address any issues that arise.
- Conduct supplier audits and assessments to ensure product quality standards are met.
7. Train and Mentor Quality Control Team
- Provide leadership and guidance to quality control staff, ensuring they understand best practices.
- Develop training programs for new hires and ongoing skill development for team members.
- Foster a culture of continuous improvement within the quality control team.
8. Ensure Compliance with Regulatory Requirements
- Stay current with medical device industry regulations and ensure the company adheres to them.
- Ensure all documentation related to quality control and compliance is properly maintained.
- Work with regulatory affairs teams to ensure products meet required safety and quality standards.
What The Client is Looking For in You
To succeed in the role of Quality Control Manager (Med Device) in St. Louis, MO, the ideal candidate must bring a combination of technical expertise, leadership skills, and a strong understanding of the medical device industry’s regulatory requirements. Specifically, the client is seeking someone with:
- Extensive Experience in Quality Control – A minimum of 5 years of experience in a quality control or quality assurance role within the medical device industry, with proven expertise in regulatory compliance and quality systems.
- Strong Regulatory Knowledge – In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other industry standards to ensure compliance in quality assurance processes.
- Leadership and Team Management Skills – Experience leading and mentoring teams, fostering a culture of quality and continuous improvement, and ensuring high standards are maintained.
- Problem-Solving and Analytical Skills – Ability to identify and resolve quality issues, analyze data, and implement effective corrective actions (CAPA) and preventative measures.
- Attention to Detail – A meticulous approach to inspecting and verifying product quality, ensuring that all products meet the highest safety and quality standards before they reach the market.
This role requires someone who thrives in a fast-paced, regulated environment and is committed to driving operational efficiency and product excellence.
Why This Opportunity Stands Out
This is a unique opportunity for a Quality Control Manager (Med Device) in St. Louis, MO to join a dynamic and innovative medical device company that is committed to excellence and continuous improvement. Why this role stands out:
- High Impact Role – You will play a key role in ensuring the safety and effectiveness of products that directly impact patients’ lives.
- Growth and Development – Work in an organization that values professional development and offers opportunities for training and career progression.
- Industry Leadership – Join a company that is well-regarded in the medical device industry, where you’ll collaborate with experts and leaders in the field.
- Competitive Compensation – Along with a competitive salary, you will receive a comprehensive benefits package, including health coverage and professional development opportunities.
This position offers a rewarding opportunity to shape the future of quality in a company that is at the forefront of medical device innovation.
FAQs About the Role
Q: What is the required experience for this role?
A: The ideal candidate should have at least 5 years of experience in quality control or assurance in the medical device industry, including experience with FDA regulations and ISO standards.
Q: Is relocation required for this position?
A: The role is based in St. Louis, MO. Candidates must either be local or willing to relocate. A relocation package may be offered to the right candidate.
Q: What is the reporting structure for this role?
A: The Quality Control Manager (Med Device) will report directly to the Director of Quality Assurance and work closely with cross-functional teams, including R&D and production.
Q: What qualifications and certifications are required for this role?
A: A bachelor’s degree in a related field (e.g., engineering, life sciences) is required. Additional certifications such as Six Sigma or Quality Control/Quality Assurance certifications are highly desirable.
Q: What is the expected travel requirement for this role?
A: Some travel may be required for supplier visits, audits, or training sessions, but the majority of work will be based at the company’s St. Louis facility.
Q: What is the work environment like for this position?
A: You will be working in a collaborative, fast-paced environment with a focus on continuous improvement and quality excellence. The company fosters a culture of teamwork and professional growth.
Q: What kind of leadership is expected in this role?
A: The Quality Control Manager (Med Device) is expected to provide strong leadership, guiding the quality team and ensuring that all quality standards are met while driving continuous improvement.
Q: What kind of impact will this role have on the company?
A: This position will be crucial in ensuring that products meet the highest quality standards, directly impacting the company’s reputation, regulatory compliance, and customer satisfaction.
What Remuneration Can You Expect from This Job?
As the Quality Control Manager (Med Device) in St. Louis, MO, you can expect a competitive remuneration package designed to reflect your skills, experience, and leadership in the medical device industry. The base salary for this position typically ranges from $90,000 to $120,000 annually, depending on your qualifications and relevant industry experience.
In addition to the base salary, the role offers a performance-based bonus structure that rewards individual and team achievements. Bonuses are tied to specific quality metrics, regulatory compliance targets, and operational excellence. This ensures that your contributions to the company’s growth and reputation are recognized and rewarded.
The compensation package also includes comprehensive benefits, such as healthcare (medical, dental, and vision), a 401(k) retirement plan with company matching, paid time off, and other employee benefits. For candidates relocating to St. Louis, a relocation package may be available to assist with the transition.
Furthermore, the opportunity to work in a cutting-edge industry like medical devices offers the chance to further develop your career, gain additional training, and grow into senior management positions as the company continues to expand.
How to Apply for This Quality Control Manager (Med Device) Position in St. Louis, MO
If you are an experienced Quality Control Manager (Med Device) with a passion for maintaining the highest standards of quality and compliance in the medical device industry, we invite you to apply for this exciting opportunity in St. Louis, MO.
To apply, please submit your resume and a cover letter outlining your experience in quality control, regulatory compliance, and medical device manufacturing. Be sure to highlight your leadership experience and any relevant certifications or qualifications that would make you an ideal candidate for the role.
This role offers a rewarding opportunity to be part of an innovative company, ensuring that high-quality medical devices are brought to market. Apply today to take the next step in your career as a Quality Control Manager (Med Device) in St. Louis, MO!
For more information or to explore similar opportunities, visit our Medical Device Recruiters page .
Tags: Quality Control Manager | Medical Device Quality | Quality Assurance | St. Louis, MO Jobs | FDA Compliance | ISO 13485 | Medical Device Manufacturing
