Overview
We are seeking a hands-on quality assurance engineer with strong manufacturing, root-cause analysis, and quality systems experience. This hybrid Quality/Manufacturing role owns key elements of the Quality Management System (QMS), including Nonconformance Management, Equipment Qualification/Calibration, Incoming and In-Process Inspection, and Supplier Quality, while contributing to improving product quality, cost, and manufacturability.
Responsibilities
- Lead investigations and manage dispositions for all manufacturing nonconformances.
- Review, optimize, and validate manufacturing processes for quality and regulatory compliance.
- Own tooling and equipment qualification and calibration.
- Manage supplier quality, including evaluations, audits, and SCARs.
- Drive internal CAPAs tied to manufacturing issues.
- Track production data, identify trends, and drive continuous improvement efforts.
- Train and support the team on QMS processes, GMP, and process controls.
- Maintain and improve manufacturing documentation, inspection procedures, and Device History Records.
Required Qualifications
- Bachelor’s degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering; or 8+ years of relevant experience.
- 3+ years in a regulated environment (medical devices preferred).
- Clear, concise technical writing skills.
- Working knowledge of QMS elements such as CAPA, Training, Nonconformance, and Change Control.
- Familiarity with ISO 13485.
- Comfortable supporting internal and external audits.
Skills That Will Make You Successful
- Practical experience in manufacturing and quality engineering.
- Detail-oriented mindset with a focus on mistake-proofing.
- Solid engineering fundamentals: materials, manufacturing, test methods, and root cause analysis.
- Clear communicator with both technical and nontechnical stakeholders.
- Collaborative team player and proactive problem solver.
The company provides a comprehensive benefits package, including medical insurance, dental reimbursement, 15 days of paid time off (PTO) plus federal holidays, and a 401(k) plan with both pre-tax and Roth options.