The Quality Assurance Manager leads the quality and regulatory department for Camber Spine. Specifically, this role will plan, coordinate, and manage the quality assurance (QA) activities associated with all quality management system (QMS) requirements per ISO 13485 and 21 CFR 820. This individual will manage the department and be part of the daily QMS activities including but not limited to, remediation, audit planning and oversight, management review, change control, nonconformances, CAPAs, complaints, inspection and other QMS requirements. This role will also be part of the product development (PD) QA activities, as well as participate as an active QA representative on project teams. Finally, this role will support regulatory submissions as needed. This position reports to the Chief
Executive Officer.
Responsibilities
- Manage the quality and regulatory department’s strategy, resources and activities.
- Lead internal and external audits, including notified body audits. Participate and/orlead supplier audits.
- Oversee and manage the supplier control activities.
- Conduct management review meetings and oversee trending documentation.
- Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
- Lead teams for Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures.
- Participate in Quality Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyzes customer/internal complaints.
- Monitor field quality and analyze field returns to determine root cause.
- Provide training and support for quality system processes and quality engineering practices.
- Support tissue banking activities as deemed necessary to meet regulatory requirements (i.e., receipt, storage, handling, distribution, Quality and Regulatory controls).
- Support regulatory submissions.
- Other activities as assigned.
Qualifications
- BS/BA Engineering, life sciences, or similar.
- 8-10 years in medical device quality assurance or engineering.
- Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and other related medical device standards.
- Experience working per 21 CFR Part 1271 and applicable state licensing requirements preferred, but not required. Willingness to be trained upon hire.
- Self-motivated and able to balance multiple priorities and tight deadlines with minimal supervision.
- Excellent communication skills — verbal and written.
