Manager, Quality Control
About The Position
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. The Manager, Quality Control is responsible for leading and managing Quality Control (QC) activities to ensure products meet internal specifications, regulatory requirements, and meet customer expectations. This role oversees inspection processes, training and development of QC staff, maintenance of quality records, and execution of continuous improvement initiatives within a regulated medical device manufacturing environment.
Requirements
- Bachelor’s degree in Science, Engineering, or related field with a minimum of 8 years of related Quality Control or manufacturing experience; or Master’s degree in a related field with a minimum of 5 years of relevant experience.
- Experience within the medical device industry.
- Strong knowledge of Quality Systems, including QMS, SOPs, Work Instructions, DHR, DMR, and GDP.
- Advanced experience with nonconformance management, CAPA processes, and quality measurement tools.
- Demonstrated ability to supervise, mentor, coach, and train others.
- Excellent written and verbal communication skills, with the ability to present information to senior management.
- Strong leadership and people-management capabilities.
- High attention to detail with a structured, analytical approach.
- Effective problem-solving and decision-making skills.
- Ability to manage complex initiatives in a fast-paced environment.
- Collaborative mindset with strong cross-functional communication skills.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Nice To Haves
- Deep knowledge of GMP, ISO regulations, and validation standards.
- Experience implementing and maintaining effective risk mitigation strategies within QC processes.
- Certifications from an accredited quality or engineering association.
- Proven project management and cross-functional leadership experience.
Responsibilities
- Establish, implement, and maintain effective Quality Control processes in alignment with company policies and global regulatory standards.
- Ensure product quality compliance with internal requirements, FDA regulations, ISO standards, and applicable global regulations.
- Develop, monitor, and analyze QC-related metrics; guide corrective actions and continuous improvement efforts.
- Maintain up-to-date knowledge of Quality Control techniques, company products, and manufacturing process technologies.
- Hire, manage, and maintain appropriate staffing levels for Quality Control technicians.
- Develop training materials and ensure ongoing competency and qualification of QC staff.
- Promote awareness of regulatory and quality requirements throughout the organization.
- Review and manage nonconformance reports; oversee CAPA activities related to QC processes.
- Collaborate with Manufacturing, Engineering, and Supplier Quality teams on root cause analysis and corrective actions.
- Track, trend, and analyze quality data to identify risks and improvement opportunities.
- Support implementation of product and process risk management activities in accordance with FDA and ISO standards.
- Provide active, hands-on involvement in complex problem solving and risk mitigation activities.
- Lead and support multiple projects simultaneously while ensuring timely and compliant execution.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
