What are the responsibilities and job description for the MANAGER, MANUFACTURING QUALITY position at Gables Search Group?
Our company specializes in manufacturing medical instruments and we are currently seeking a Manufacturing Quality Supervisor in Budd Lake, NJ. The ideal candidate will be a proactive leader who fosters a strong culture of quality and compliance, develops team members, enhances manufacturing controls, and collaborates with various departments such as Operations, Engineering, and Supply Chain. This role presents an exciting opportunity to influence the role of quality in ensuring consistent execution, ongoing enhancement, customer trust, and sustainable expansion. The responsibilities include overseeing and improving the manufacturing quality system, as well as guiding and developing the quality team.
Qualifications:
- A Bachelor’s Degree in science, engineering, or a related field is mandatory, while a Master’s degree is desirable.
- At least 7 years of experience in a medical device manufacturing setting is required.
- Minimum of 3 years in a leadership or supervisory role.
- Proven track record in manufacturing quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation or qualification activities.
- Thorough understanding of quality system standards like ISO 13485, FDA 21 CFR 820 (QMSR), and ISO 14971 risk management principles, and the ability to apply these standards in a practical manufacturing environment.
- Proficiency in Microsoft Office applications and the willingness to learn and utilize quality and manufacturing systems.
- ASQ certifications will be advantageous.
- Expected to travel up to 10% of the time, including domestic and international trips.
Contact us for further information.