Senior Quality Control Compliance Engineer

Rust Belt Recruiting; Newbury Township (OH); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

HSA

Life insurance

401(k) with match

Paid time off

Company holidays

Job summary

Rust Belt Recruiting seeks a Senior Quality Control & Compliance Engineer responsible for overseeing day-to-day quality control operations and maintaining robust compliance programs for high-reliability electronics and medical devices. You will resolve quality issues, manage QMS activities, and ensure ISO 9001, ISO 13485, and FDA QSR adherence.

Ideal candidates have at least 5 years in electronics manufacturing quality/compliance, with ASQ certifications preferred, and must be able to commute to

Qualifications

• Bachelor's degree in Engineering or related technical field.
• At least 5 years of quality and compliance experience in electronics manufacturing, preferably medical devices.
• Solid knowledge of ISO 9001 and ISO 13485 plus FDA QSR requirements.
• Experience supporting quality inspections, handling customer complaints, and creating documentation.
• Ability to commute daily to Newbury, OH 44065 and work in-person.

Responsibilities

• Collaborate with production, engineering, and supply chain to investigate and resolve quality issues.
• Manage customer complaints end-to-end with root-cause analysis and corrective actions.
• Provide technical support to inspectors for incoming material and finished product checks.
• Create and maintain quality documents, procedures, and device history files.
• Monitor key quality metrics and report trends to drive process improvements.
• Maintain QMS elements in line with ISO 9001 and ISO 13485 standards and FDA expectations.
• Lead internal, customer, and third-party audits; support FDA inspections readiness.
• Keep regulatory filings and technical documentation current and audit-ready.

Skills

Regulatory compliance

Quality assurance

Analytical thinking

Communication

Team collaboration

Education

Bachelor's degree in Engineering

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

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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