Sr. Quality Control Supervisor
About the role
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.
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.
Requirements
- 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.
- Able to effectively lead teams, manage performance, and resolve conflicts.
Qualifications
- Good To Have: ASQ certifications (e.g., CQI, CQT, Six Sigma Green Belt) preferred.
Benefits
Cirtec Medical Corporation provides 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.
Pay
$80,000 to $127,000 based on skills and experience.
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