Senior Quality & Compliance Engineer - On-Site

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

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.