Senior Quality Control & Compliance Engineer
$85,000–$100,000 year
On-siteCovington, Ohio, United States
Job Summary
Collaborate with production, engineering, and supply chain teams to investigate and resolve quality issues and handle customer complaints end-to-end through root-cause analysis. Provide technical support to inspectors for incoming material and finished product quality checks on electronic devices, cable assemblies, and medical products. Create, review, and maintain quality documentation including procedures, inspection plans, and device history files while executing Quality Management System elements under ISO 9001 and ISO 13485 standards. Monitor defect rates and complaint trends to contribute to process improvements and lead internal, customer, and third-party certification audits. Maintain regulatory filings and technical documentation to ensure they remain current and audit-ready for FDA compliance activities.
Required Qualifications
- Bachelor's degree in Engineering, Quality Assurance, Regulatory Affairs, or a related technical field (or equivalent experience)
- Minimum of 5 years of experience in quality and compliance within electronics manufacturing, preferably with medical devices and cable/electronic assemblies
- Solid working knowledge of ISO 9001, ISO 13485, and FDA Quality System Regulation (QSR) requirements
- Proven experience supporting quality inspections, managing customer complaints, and creating quality documentation
- Strong organizational, communication, and problem-solving skills with high attention to detail
- Ability to work collaboratively within a team environment while maintaining individual accountability
- Ability to commute daily in-person to Newbury, OH 44065
Desired Qualifications
- Preferred credentials such as ASQ certifications (CQE, CQA) or regulatory affairs certifications (RAC)
- Preferred familiarity with risk management (ISO 14971), validation processes, and statistical quality tools like SPC and Gage R&R
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