What are the responsibilities and job description for the Quality Assurance Manager position at ContinuitiHR?
Job Summary
Our client is seeking an experienced detail-oriented QA/QC Manager with at least 5 years of experience as a licensed pharmacist in the medical device industry. This role is critical in ensuring product quality and regulatory compliance while fostering continuous improvement across the company. The QA/QC Manager will oversee quality assurance and quality control operations while driving excellence in the manufacturing processes and compliance with global standards.
- Develop, implement, and maintain the QMS in alignment with ISO13485 and other global standards.
- Establish, document, and enforce quality policies, procedures, and SOPs.
- Lead internal and external audits, including supplier audits, regulatory inspections, ensuring compliance and timely resolution of non-conformities.
- Manage change control processes and ensure proper validation of new equipment, processes, and systems.
- Oversee QC processes for raw materials, in process products, and finished products to ensure compliance with specifications.
- Analyze quality metrics and trends to identify potential risks and implement corrective actions.
- Collaborate with the production team to resolve quality issues and implement preventative measures.
- Maintain up-to-date knowledge of regulatory requirements for medical devices, including ISO standards and FDA regulations.
- Ensure product documentation and labeling meet regulatory requirements.
- Prepare for and participate in regulatory submissions, inspections, and audits.
- Lead, mentor, and manage the QA/QC team to meet organizational quality objectives.
- Provide training to staff on quality standards, compliance, and operational excellence.
- Foster a culture of quality and continuous improvement across the organization.
- Identify opportunities for process optimization and cost efficiency while maintaining high quality standards.
Requirements:
- Minimum of 5 years of experience as a NJ licensed pharmacist in the medical device industry.
- Bachelor’s degree in Pharmacy, Master’s degree a plus.
- Strong knowledge of ISO 13485 and other global regulatory standards for medical devices.
- Experience in managing quality audits, regulatory inspections, and compliance programs.
- Proficient in quality tools such as CAPA and statistical analysis/reporting.
- (Team of 4)
- Excellent leadership, communication, and problem-solving skills.
Join us in our commitment to excellence by applying your expertise as a Quality Assurance Manager. Your contributions will play a vital role in delivering high-quality products that meet our customers' needs.
Job Type: Full-time
Pay: $120,000.00 - $130,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Education:
- Master's (Preferred)
Experience:
- Licensed Pharmacist: 5 years (Required)
- ISO 13485: 5 years (Preferred)
- CAPA: 5 years (Required)
License/Certification:
- Licensed Pharmacist (Required)
Ability to Commute:
- Jersey City, NJ 07302 (Required)
Ability to Relocate:
- Jersey City, NJ 07302: Relocate before starting work (Required)
Work Location: In person
Salary : $120,000 - $130,000