Sr Quality Control and 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 company match

Paid time off

Company holidays

Professional development

Job summary

Rust Belt Recruiting is partnering with a military communications and medical device manufacturer in Newbury, OH to hire a Quality Control and Compliance Coordinator. You will oversee daily quality operations, including incoming inspection, customer complaints, and documentation, while executing ISO 9001, ISO 13485, and FDA QSR compliance.

The role requires a Bachelor's in Engineering or a related field and at least 5 years of quality/compliance experience in electronics manufacturing, with ASQ

Qualifications

• Bachelor’s degree in Engineering, QA, Regulatory Affairs, or related field
• 5+ years in quality/compliance in electronics manufacturing, preferably medical devices/cable assemblies
• Strong knowledge of ISO 9001 and ISO 13485 plus FDA QSR requirements
• Experience supporting inspections, handling customer complaints, and creating documentation
• Excellent organizational, communication, and problem-solving skills

Responsibilities

• Collaborate with production, engineering, and supply chain to investigate and resolve quality issues
• Manage end-to-end customer complaints with root-cause analyses and corrective actions
• Provide technical support to inspectors for incoming material and finished product checks
• Create, review, and maintain quality documents including procedures and records
• Monitor defect rates and complaint trends to drive process improvements
• Maintain QMS elements in accordance with ISO 9001 and ISO 13485
• Support FDA compliance activities for medical device production
• Assist internal, customer, and third-party audits and prep for FDA inspections
• Maintain regulatory filings and quality records to ensure audit readiness

Skills

Quality Assurance

Regulatory Compliance

Root Cause Analysis

Documentation

Problem Solving

Team Collaboration

Education

Bachelor’s degree in Engineering/QA/Regulatory Affairs

Tools

QMS (ISO 9001, ISO 13485)

FDA QSR

Job description

Title: Quality Control and Compliance Coordinator

Shift: Condensed Schedule | 9 hours per day Monday through Thursday, 4 hours on Friday

Salary: $85,000 - $100,000 per year, plus a performance-based bonus; exact compensation is dependent on experience

Quality Control and Compliance Coordinator Role:

Our client is seeking a detail-oriented professional to support their corporate compliance program and manage hands-on quality control activities. This role exists to oversee daily quality operations—such as incoming inspection protocols, customer complaints, and quality document creation—while executing ISO 9001, ISO 13485, and FDA regulatory compliance tasks to protect product integrity.

Quality Control and Compliance Coordinator Responsibilities:

• Collaborate closely with production, engineering, and supply chain teams to systematically investigate and resolve active quality issues
• Handle the customer complaint process end-to-end by conducting root-cause analyses with cross-functional teams and documenting corrective actions
• Provide technical support to inspectors regarding incoming material and finished product quality checks for electronic devices, cable assemblies, and medical products
• Create, review, and maintain vital quality documentation including procedures, inspection plans, quality records, and device history files
• Monitor and report on key quality metrics such as defect rates and complaint trends to actively contribute to process improvements
• Execute and maintain foundational elements of the Quality Management System (QMS) in accordance with ISO 9001 and ISO 13485 standards
• Support ongoing FDA compliance activities for medical device production to safeguard regulatory alignment
• Participate in internal, customer, and third-party certification audits, and assist with hands-on preparation for formal FDA inspections
• Maintain regulatory filings, technical documentation, and quality records to ensure the facility remains audit-ready at all times

Quality Control and Compliance Coordinator Reporting Relationships:

The Quality Control and Compliance Coordinator reports directly to the Engineering Manager. This position serves as a key compliance anchor, working collaboratively with laboratory inspectors, engineers, and production staff.

About You:

• Possess a Bachelor’s degree in Engineering, Quality Assurance, Regulatory Affairs, or a related technical field (or equivalent professional experience)
• Hold a minimum of 5 years of experience in quality and compliance within electronics manufacturing, preferably dealing with medical devices and cable/electronic assemblies
• Demonstrate a solid working knowledge of ISO 9001 and ISO 13485 requirements alongside FDA Quality System Regulations (QSR)
• Maintain extensive experience supporting quality inspections, managing customer complaints, and creating rigorous quality documentation
• Exhibit strong organizational, communication, and problem-solving skills with a high level of attention to detail
• Demonstrate the ability to work collaboratively within a team environment while maintaining individual accountability for tasks
• Hold preferred qualifications such as ASQ certifications (CQE, CQA), regulatory affairs certifications (RAC), or familiarity with risk management (ISO 14971)
• Bring preferred experience with electronic components, validation processes, and statistical quality tools like SPC and Gage R&R
• Maintain the reliable ability to commute daily to the facility in 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.
• About the Client: Our client is a recognized leader in military communications and medical device manufacturing, offering a collaborative culture that values quality, integrity, and innovation.
• Benefits Offered: This permanent position features a comprehensive benefits package including health, dental, vision, an HSA, life insurance, a 401(k) with company match, paid time off, company holidays, and clear opportunities for professional development and internal growth.

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