Sr. Quality Control Supervisor

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Senior Supervisor, Quality Control leads daily quality control operations to ensure products meet internal standards, regulatory requirements, and customer expectations. This role partners closely with Engineering and Production to support manufacturing schedules, drive continuous improvement, and maintain compliance with applicable quality systems (e.g., GMP, GDP). The position also plays a key role in team leadership, problem-solving, and process optimization.

Key Responsibilities:

• Lead and prioritize quality control activities to support production and engineering needs.
• Supervise inspection activities, including incoming, in-process, and final product inspections.
• Coach, develop, and manage quality inspectors and technicians; support onboarding and training.
• Partner with Quality Engineering on investigations, root cause analysis, and corrective actions.
• Oversee disposition of nonconforming materials and support material review processes.
• Monitor inspection data, identify trends, and drive improvements using SPC and data analysis.
• Ensure compliance of Device History Records (DHRs) with GMP and GDP requirements.
• Develop, maintain, and improve inspection plans, procedures, and quality control documentation.
• Support product transfers from development to production, ensuring quality readiness.
• Coordinate measurement system analysis (MSA) activities and inspection methods.
• Verify environmental monitoring results and support cleanroom compliance, as applicable.
• Generate Certificates of Conformity and maintain accurate quality records in PLM systems.
• Recommend tools, equipment, and process improvements to enhance quality and efficiency.

Must Have:

• Bachelor's degree in Quality, Engineering, or a related STEM field (or equivalent experience).
• 5-7 years of experience in Quality Control/Quality Assurance, preferably in the medical device industry.
• Prior supervisory or team leadership experience required.
• Strong knowledge of GMP, GDP, and quality systems in a regulated environment.
• Experience with SPC, root cause analysis, and continuous improvement methodologies.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and quality data analysis tools.
• Strong communication, organizational, and problem-solving skills.
• Ability to effectively lead teams, manage performance, and resolve conflicts.

Good to have:

• ASQ certifications (e.g., CQI, CQT, Six Sigma Green Belt) preferred.

Salary Range: 80,000 to 127,000 based on skills and experience.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.