Overview
The Lead Quality Assurance Engineer is responsible for establishing, maintaining, and improving the Quality Management System (QMS) to ensure effective operations, regulatory compliance, and the highest standards of product and service quality. This role fosters a results-driven culture centered on customer and employee satisfaction, operational excellence, and continuous improvement. By leading with integrity, inspiring teams, and driving alignment with organizational goals, the Lead QA Engineer plays a critical role in surpassing performance objectives and supporting long-term business success.
Responsibilities
- Mentor design teams on Design Controls, Risk Management, and Electrical Safety to ensure safe, compliant devices.
- Review and approve Engineering Change Orders and design changes for sound engineering, safety, and compliance.
- Oversee manufacturing quality processes, including nonconforming material handling, inspections, and DHR/DMR compliance.
- Manage QMS activities such as audits, CAPA, change control, supplier quality, and external audit support.
- Ensure post-market monitoring, defect handling, and performance trend analysis to drive improvements.
- Support new product development, sustaining engineering, and regulatory submissions with quality oversight.
- Maintain and update procedures to ensure compliance with ISO 13485, MDR/MDSAP, and global regulatory standards.
- Track and report quality metrics, facilitating timely corrective actions and process improvements.
- Collaborate cross-functionally to integrate quality into design, manufacturing, and regulatory planning.
- Promote a culture of quality, ethics, and continuous improvement across all teams.
Requirements
- Bachelor’s degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical).
- 7+ years related Quality / Engineering work experience.
- 5+ years of experience with medical device regulatory and quality and Quality Management Systems.
- Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation.
- Experience with statistical analysis.
- Knowledge of Software as a Medical Device (SaMD) or Software within a device required.
- Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards.
Preferred
- Experience acting as a Change Agent.
- Experience with FDA 21 CFR 820, 21 CFR 11, 21 CFR 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223, EN ISO 20417, EN 62304, Cybersecurity, IEC 60601-1, ISO 27001 and 14001.
- Experience with medical device electrical safety standards.
- Creative problem solving, flexibility, and good negotiation skills.
- Some travel may be necessary both domestic and international, less than 5%.
Location: WA
Employment Type: Full-time, Hybrid Remote
This job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization's ongoing needs.
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