Description
Finish Line Staffing Services is hiring a Senior / Principal Quality Systems Engineer for our client, a medical device company developing and manufacturing sterile catheter-based, software-enabled, and electromechanical medical devices.
This position will play a key role in maintaining and continuously improving the company’s Quality Management System (QMS) while providing hands-on Quality Engineering support across manufacturing operations. The ideal candidate brings strong medical device quality systems experience and is comfortable working within a collaborative, fast-paced environment.
Responsibilities
Quality Management System
- Maintain and continuously improve a QMS compliant with FDA Quality Management System Regulation (QMSR) requirements and ISO 13485.
- Support the development and improvement of SOPs, work instructions, forms, test protocols, and other controlled documentation.
- Support document control and quality records management requirements.
- Lead and support CAPA investigations, including root cause analysis, timely closure, and effectiveness verification.
- Participate in internal audits and support regulatory, supplier, and other external audits.
- Develop and analyze quality metrics to support risk-based decision-making and continuous improvement.
- Support ongoing regulatory compliance and inspection readiness.
Operations & Supplier Quality
- Partner with Operations to ensure manufacturing processes are appropriately controlled and validated.
- Contribute to risk management, sterilization validation, and data integrity activities.
- Support incoming inspection, nonconforming material control, and material disposition.
- Provide Quality Engineering support for manufacturing infrastructure, process improvements, and expansion initiatives.
- Support supplier qualification, evaluation, and ongoing performance monitoring.
- Participate in supplier audits and review supplier corrective action responses.
Post-Market Quality
- Support complaint handling, Medical Device Reporting (MDR), and trend analysis activities.
- Monitor relevant regulatory requirements and industry standards and communicate applicable changes to the team.
- Assist with preparation for FDA inspections and Notified Body audits.
Leadership & Quality Culture
- Promote a proactive, collaborative quality culture across a multidisciplinary organization.
- Provide quality systems guidance, training, and mentoring to team members.
- Serve as a Quality Engineering resource across functions and support continuous improvement initiatives.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- Minimum of 5 years of quality systems experience within medical device manufacturing.
- Demonstrated experience implementing, maintaining, and improving medical device Quality Management Systems.
- Strong knowledge of FDA QMSR requirements, ISO 13485:2016, and ISO 14971.
- Hands-on experience with key QMS processes, including CAPA, document control, complaint handling, internal auditing, and supplier quality.
- Strong technical writing skills with the ability to develop clear, accurate, and compliant quality documentation.
- Experience applying statistical techniques, sampling plans, and data analysis to validation and process capability activities.
- Ability to work effectively across Quality, Operations, Engineering, and other technical functions.
Finish Line Staffing Services is recruiting for this opportunity on behalf of our client. Qualified candidates with strong medical device Quality Systems experience are encouraged to apply.