Senior Quality Control & Compliance Engineer - Medical Devices

Rust Belt Recruiting; Newbury Township (OH); Sur place; USD 85 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

HSA

Life insurance

401(k) with match

Paid time off

Company holidays

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory compliance

Quality assurance

Analytical thinking

Communication

Team collaboration

Formation

Bachelor's degree in Engineering

Description du poste

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