Title: Senior Quality Control & Compliance Engineer
Shift: Condensed Schedule | 9 hours per day Monday through Thursday, 4 hours on Friday
Salary: $85,000 - $100,000 per year, plus performance-based bonus; exact compensation is dependent on experience
Senior Quality Control & Compliance Engineer Role:
Our client is seeking a detail-oriented professional to oversee day-to-day quality control operations and execute comprehensive compliance programs. This role exists to resolve quality issues, maintain Quality Management Systems, and satisfy ISO and FDA regulatory requirements to ensure product integrity across high-reliability electronics and medical devices.
Senior Quality Control & Compliance Engineer Responsibilities:
Collaborate with production, engineering, and supply chain teams to investigate and resolve quality issues
Handle the customer complaint process end-to-end through root-cause analysis, corrective actions, and documentation
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, quality records, and device history files
Monitor and report on key quality metrics like defect rates and complaint trends to contribute to process improvements
Execute and maintain elements of the Quality Management System (QMS) in accordance with ISO 9001 and ISO 13485 standards
Support FDA compliance activities for medical device production
Lead internal audits, customer audits, and third-party certification audits while assisting with preparation for FDA inspections
Maintain regulatory filings, technical documentation, and quality records to ensure they remain current and audit-ready
Senior Quality Control & Compliance Engineer Reporting Relationships:
The Senior Quality Control & Compliance Engineer reports directly to the Engineering Manager. This position functions as an individual contributor and technical mentor without direct supervisory reports.
About You:
Possess a Bachelor’s degree in Engineering, Quality Assurance, Regulatory Affairs, or a related technical field (or equivalent experience)
Hold a minimum of 5 years of experience in quality and compliance within electronics manufacturing, preferably with medical devices and cable/electronic assemblies
Demonstrate solid working knowledge of ISO 9001, ISO 13485, and FDA Quality System Regulation (QSR) requirements
Exhibit proven experience supporting quality inspections, managing customer complaints, and creating quality documentation
Demonstrate strong organizational, communication, and problem-solving skills with high attention to detail
Maintain the ability to work collaboratively within a team environment while maintaining individual accountability
Hold preferred credentials such as ASQ certifications (CQE, CQA) or regulatory affairs certifications (RAC)
Demonstrate preferred familiarity with risk management (ISO 14971), validation processes, and statistical quality tools like SPC and Gage R&R
Possess the ability to commute daily in-person to Newbury, OH 44065
Next Steps:
If you are a self-motivated problem-solver and detail-oriented professional, we would like to hear from you. Please reach out to our recruiting agency today to discuss this opportunity with our client.
Additional Information:
Equal Opportunity Employer: Our client provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics
Working Conditions: This is a full-time, in-person role located at the facility in Newbury, OH 44065
Benefits Package: Position offers a comprehensive benefits package including health, dental, vision, HSA, life insurance, 401(k) with match, paid time off, and company holidays
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