What are the responsibilities and job description for the Quality Assurance Manager position at Suru?
Our client is a mid-size medical device manufacturer located in Sussex County, NJ. They are currently in need of a quality manager to oversee their cleanroom facility.
The Quality Manager is responsible for overseeing and ensuring compliance with quality standards in a cleanroom manufacturing facility focused on the production of medical tubing and filling needles. This individual will lead quality assurance activities, manage cleanroom operations, maintain compliance with regulatory standards such as ISO 13485 and FDA 21 CFR Part 820, and support continuous improvement initiatives. The Quality Manager will also lead and support internal and external audits, implement quality systems, and ensure the highest standards of product quality are maintained.
Responsibilities Include:
Quality Management System (QMS):
- Oversee and maintain the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and GMP standards.
- Develop, implement, and maintain quality policies, procedures, and work instructions to ensure product quality and regulatory compliance.
- Lead internal and external audits, including audits from regulatory agencies and customers.
- Manage non-conformances, corrective and preventive actions (CAPA), and customer complaints.
- Lead investigations related to product quality issues and implement effective root cause analysis and corrective actions.
Cleanroom Facility Management:
- Oversee cleanroom operations, ensuring compliance with cleanroom classifications and environmental control standards.
- Implement and maintain cleanroom monitoring procedures, including particle counts, microbiological testing, and cleaning protocols.
- Ensure all cleanroom personnel are trained and adhere to gowning, hygiene, and cleanroom behavior requirements.
- Collaborate with production teams to minimize contamination risks and maintain high product quality standards.
- Manage and monitor cleanroom environmental controls to maintain proper conditions for medical device production.
Product Quality Assurance:
- Ensure all medical tubing and filling needle products meet defined quality specifications and customer requirements.
- Develop and maintain product inspection criteria, sampling plans, and test methods to verify product quality.
- Review and approve batch records, production documentation, and device history records (DHRs).
- Lead or assist in the validation of production processes, including IQ/OQ/PQ for cleanroom operations and equipment.
Requirements:
- Bachelor’s degree in Engineering, Quality Management, Life Sciences, or a related field.
- Minimum of 5-7 years of experience in medical device manufacturing, with at least 3 years of experience in a cleanroom environment.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
- Experience managing cleanroom operations in a regulated manufacturing environment.
- Demonstrated experience with CAPA, root cause analysis, non-conformance management, and process validation (IQ/OQ/PQ).
- Strong leadership and team management skills.
- Excellent problem-solving and analytical abilities.
- Proficient in using quality management software (QMS) and Microsoft Office applications.
