Quality Systems Engineer

The Quality System Specialist supports the Quality System Manager in maintaining and continuously improving the Quality Management System, with responsibility for quality document lifecycle management, CAPA administration, certification-maintenance activities, and audit and management review support.

• Prepare, review, and approve quality system documents (procedures, work instructions, forms) for accuracy, compliance, and consistency prior to release.
• Administer the CAPA program - review and route CAPA records, verify root cause analysis and corrective/preventive action plans are documented, track action items to closure, and confirm effectiveness checks are completed and recorded.
• Trend CAPA and audit data for review at quality system management reviews.
• Support certification-maintenance activities for ISO 13485, MDSAP, and MDD/MDR certifications, including gathering evidence, preparing documentation packages, and tracking certification and recertification timelines.
• Support planning and execution of the internal audit program - scheduling audits, preparing audit checklists, participating in or leading internal audits, documenting findings, and tracking corrective actions to closure.
• Support preparation for and execution of external audits (Notified Body/Registrar, FDA), including hosting auditors and coordinating evidence retrieval.
• Support preparation of inputs for quality system management reviews, including compiling data on quality objectives, audit results, CAPA/PA trends, and complaint/post-market surveillance data.
• Partner with the Quality System Manager on continuous improvement of QMS processes.

• Bachelor's degree in a technical, scientific, or quality-related field.
• 3-5 years of quality assurance experience at a medical device manufacturer.
• Working knowledge of ISO 13485 and 21 CFR 820.
• Demonstrated experience with document control, CAPA, or internal audit processes.
• Proficient with standard office software (Microsoft Office suite or equivalent).

• ASQ certification (CQA or CQE).
• ISO 13485 Lead/Internal Auditor certification.
• Experience with EU MDR requirements and MDSAP.
• Experience hosting Notified Body/Registrar auditors or FDA investigators during on-site inspections is a plus.
• Experience with ERP systems and eQMS platforms, specifically Compliance Quest, is a plus.

• Work is primarily performed in an office and light-manufacturing/lab environment.
• Requires the ability to sit or stand for extended periods, use a computer workstation, and occasionally lift up to 25 lbs.
• Reasonable accommodations will be made for individuals with disabilities to perform essential job functions.