Senior Quality Control & Compliance Engineer - Medical Devices

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

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