The Quality Assurance Manager (QAM) is a new position and our client is looking to hire immediately!! The QAM will be hands-on and interface and collaborate with internal team members, regulatory officials, auditors, contractors, consultants and external vendors. Reporting to the Plant Manager, this key leader will be accountable for the entirety of the organization’s quality system. Experience in medical devices is a plus!! There are significant opportunities to expand into a product managing role if desired.
- Develop and maintain the Quality Management Systems (QMS) in Document Control, Design Assurance, Auditing, Supplier Monitoring, CAPA, Change Control, Product Complaint and QMS-related Training Programs.
- Develop and implement the QMS programs to ensure compliance with industry regulations and standards including medical device specific and other applicable requirements.
- Ensure the creation, approval, maintenance and retention of all QS documents in a cloud-based software platform.
- Coordinate internal and external audits, monitor and audit the QMS processes for compliance, effectiveness and alignment with regulatory and statutory requirements.
- Manage, facilitate, and participate in product complaint investigations, product and materials reviews, change control and specification reviews.
- Ensure compliance and inspection readiness of quality system and facilities with regulatory standards.
- BS in a science or engineering discipline preferred.
- Proven, hands-on experience managing a QMS.
- Sound knowledge of FDA Quality System Regulations including 21 CFR Part 820.
- Solid understanding of regulatory affairs in the launch and distribution of a medical device.
- Background in the development of regulatory submissions and documentation to obtain approval.
- Understanding of sampling procedures to ensure quality control.
- Annual salary up to $120,000 depending on experience.
- Excellent benefits and compensation package.
Job Code: 14621
Please note that quoted salary ranges are not guarantees of what the final salary offers might be. Our clients base their offers on a range of variables including years of work and industry specific experience, salary history, education level, etc.