What are the responsibilities and job description for the Quality Process Specialist position at Cirtec Medical Corporation?
About us:
For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.
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 challenge, you may be a perfect fit for our team!
Position Summary
The Quality Supervisor leads and supports the quality assurance team to ensure compliance with regulatory standards and company procedures. This role oversees daily inspection activities, drives continuous improvement, manages documentation, and collaborates with cross-functional teams to resolve quality issues.
Key Responsibilities
- Train, mentor, and lead quality team members to ensure high performance and development.
- Provide technical guidance and direction to Quality Inspectors and Auditors.
- Conduct performance reviews and offer coaching and continuous feedback.
- Investigate and resolve work problems, fostering problem-solving within the team.
- Lead Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA).
- Ensure effective employee training and application of procedures.
- Collaborate with Engineering and Operations teams to resolve internal quality issues.
- Maintain and manage quality documentation such as procedures and work instructions.
- Enforce compliance with all quality, safety, and regulatory standards.
- Support validation activities (process, equipment, software).
- Work flexible hours including weekends, as required.
Supervisory Scope:
- Oversee the work of Quality Inspectors and Quality Auditors.
Must-Have Qualifications
- 35 years of quality inspection experience in a manufacturing environment.
- Strong leadership and team development skills (minimum 2 years in a leadership role preferred).
- Proficiency in Microsoft Office and Quality Management Systems (QMS).
- Strong analytical, problem-solving, and decision-making skills.
- Excellent verbal and written communication skills.
- Working knowledge of FDA 21 CFR Part 820 and ISO 13485 standards.
- Ability to interpret data and statistics; basic SPC and Lean/Six Sigma awareness.
- Ability to lift up to 50 pounds and work in physically demanding environments.
Good-to-Have Qualifications
- Bachelors degree in a scientific or engineering discipline.
- Experience in a regulated medical device manufacturing environment.
- Union experience.
- Intermediate statistical analysis and application of continuous improvement tools.
- Experience with software and equipment validation.
- Familiarity with Lean, Six Sigma, or other CI methodologies.
- Bilingual or multilingual capabilities for diverse work environments.
