Senior Quality Control & Compliance Engineer

Gilder Search Group; Newbury (OH); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision care

401(k) with match

Paid time off

Company holidays

Job summary

Gilder Search Group is seeking a Senior Quality Control & Compliance Engineer to oversee day-to-day quality control operations and implement comprehensive compliance programs for high-reliability electronics and medical devices.

You will drive quality improvements, manage QMS, and ensure ISO 9001/13485 and FDA QSR compliance, while collaborating across production, engineering, and supply chain departments. In-person, Newbury, OH.

Qualifications

• Bachelor's degree required in engineering, QA, regulatory affairs, or related field.
• Minimum 5 years of quality and compliance experience in electronics manufacturing, preferably with medical devices.
• Solid knowledge of ISO 9001, ISO 13485, and FDA QSR requirements.

Responsibilities

• Collaborate with production, engineering, and supply chain teams to investigate and resolve quality issues.
• Handle 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.

Skills

ISO 9001

ISO 13485

QSR

ASQ CQE

ASQ CQA

Risk management

SPC

Gage R&R

Regulatory affairs

Education

Bachelor’s degree in Engineering, Quality Assurance, Regulatory Affairs, or related field

Job description

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