Quality Manager (Confidential Search)
Elyria, Ohio | Full-Time | On-Site
Lead Quality. Drive Compliance. Influence Innovation.
Are you a quality leader who thrives at the intersection of regulatory compliance, operational excellence, and continuous improvement?
Do you enjoy building world-class quality systems, leading cross-functional teams, and ensuring products meet the highest standards of safety, performance, and customer satisfaction?
Our client, a well-established and growing U.S. manufacturer, is seeking an experienced Quality Manager to lead its Quality Management System (QMS) and help drive quality excellence across the organization. This confidential opportunity is ideal for a collaborative leader who enjoys partnering with engineering, manufacturing, operations, and executive leadership to strengthen quality processes while supporting continued business growth.
Why This Opportunity?
This is far more than a traditional quality management role.
You'll serve as a key leader responsible for maintaining and advancing the company's Quality Management System while ensuring compliance with FDA regulations, ISO standards, and internal quality objectives. Your leadership will directly influence product quality, regulatory compliance, manufacturing performance, and customer satisfaction.
If you're passionate about building quality into every stage of the product lifecycle and leading continuous improvement initiatives that make a lasting impact, we'd welcome the opportunity to speak with you.
What You'll Do
As the Quality Manager, you'll provide strategic and operational leadership across all aspects of quality management and regulatory compliance.
Key responsibilities include:
- Lead, maintain, and continuously improve the Quality Management System (QMS) in accordance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485:2016, and applicable regulatory requirements.
- Provide quality leadership throughout the product development lifecycle by overseeing Design Quality Assurance activities and ensuring quality is integrated into new product development.
- Serve as the organization's Management Representative during FDA inspections and ISO 13485 certification audits.
- Prepare and facilitate monthly, quarterly, and corporate Management Review activities, ensuring effective reporting of quality system performance.
- Lead the Corrective and Preventive Action (CAPA) program, including investigations, root cause analysis, implementation of corrective actions, and verification of effectiveness across multiple manufacturing operations.
- Oversee Quality Engineering activities, including Production Part Approval Process (PPAP) documentation and product quality initiatives.
- Manage product quality hold activities while partnering with manufacturing to resolve quality concerns and improve production performance.
- Support FDA recall activities and regulatory compliance initiatives.
- Develop, implement, and maintain inspection, testing, and quality procedures that ensure product compliance and operational consistency.
- Lead quality-related process improvement initiatives that improve efficiency, reduce risk, and strengthen customer satisfaction.
- Maintain training matrices and ensure employees receive required quality system training.
- Partner closely with Engineering, Manufacturing, Regulatory Affairs, Operations, and Supply Chain to support organizational quality objectives.
- Foster a culture of accountability, continuous improvement, and operational excellence throughout the organization.
What We're Looking For
The ideal candidate is a collaborative quality leader who combines regulatory expertise with strong business acumen and a passion for continuous improvement.
Qualifications include:
- Bachelor's Degree in Engineering, Science, or a related technical discipline (Master's Degree preferred)
- Minimum of five years of quality leadership experience within the medical device industry
- Previous supervisory or people leadership experience
- Strong knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485:2016
- Experience supporting or leading FDA inspections and ISO certification audits
- Demonstrated success managing CAPA systems, root cause investigations, and quality improvement initiatives
- Experience overseeing Design Quality Assurance activities throughout product development
- Knowledge of PPAP processes and Quality Engineering principles
- Strong project management, organizational, analytical, and problem-solving skills
- Proficiency with Microsoft Office, Microsoft Project, Visio, and electronic document management systems
- Excellent communication and leadership skills with the ability to influence cross-functional teams
- High ethical standards, sound judgment, and a commitment to quality excellence
Why Join This Team?
This opportunity offers the chance to:
- Lead and shape a mature Quality Management System within an established manufacturing organization.
- Serve as a key quality leader with direct visibility to executive leadership.
- Drive continuous improvement initiatives that impact products, manufacturing, and customer satisfaction.
- Influence quality strategy across product development, operations, and regulatory compliance.
- Partner with talented engineering, manufacturing, and quality professionals in a collaborative environment.
- Build a long-term career with a stable organization committed to innovation, operational excellence, and quality.
Confidential Search
This confidential search is being conducted exclusively by Strong Tower Partners.
Additional information regarding the organization, products, team structure, compensation, and long-term growth opportunities will be shared with qualified candidates during the interview process.
All inquiries will be held in the strictest confidence.
Pay: $115,000.00 - $135,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
