Senior Quality Engineer

Senior Quality Engineer

Location:

Eastern suburb of Cleveland, OH

Compensation:

The compensation will be consist of base salary commensurate with experience Performance based bonus Comprehensive benefits package (health, dental, vision, HSA, life insurance, 401k with match) Paid time off and company holidays Condensed schedule: 9-hrs per day Monday through Thursday, 4-hrs on Friday

Opportunity Summary:

We’re partnering with an innovative and growing design and manufacturing company that delivers custom mechanical, electrical, and electro-mechanical solutions to the Military, Defense, and Medical Device industries. This privately held, financially strong organization is poised for significant growth, and they’re currently seeking to add a Senior Quality Engineer to their team. This role is responsible for supporting day-to-day quality operations (incoming inspection protocols, customer complaints, and quality document creation), executing ISO 9001 and ISO 13485 compliance tasks, and supporting FDA regulatory requirements for medical devices. This position will report to the Engineering Manager, and is based at the company headquarters in an eastern suburb of Cleveland, OH. The company provides opportunities for professional development and growth within a dynamic manufacturing environment, and a collaborative culture that values quality, integrity, and innovation.

Job Duties:

Quality Control Operations

• Collaborate with production, engineering, and supply chain teams to investigate and resolve quality issues.
• Handle the customer complaint process end-to-end: investigation and root-cause analysis with cross functional team, corrective actions, and documentation.
• Provide technical support to inspectors for incoming material and finished product quality checks for 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 (e.g., defect rates, complaint trends) and contribute to process improvements.

Compliance Activities

• 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.
• Participate in internal audits, customer audits, third-party certification audits, and assist with preparation for FDA inspections.
• Maintain regulatory filings, technical documentation, and quality records to ensure they remain current and audit-ready.

Requirements:

Required

• Bachelor’s degree in Engineering, Quality Assurance, Regulatory Affairs, or a related technical field (or equivalent experience).
• Minimum 5 years of experience in quality and compliance within electronics manufacturing, preferably with medical devices and cable/electronic assemblies.
• Solid working knowledge of ISO 9001 and ISO 13485 requirements.
• Working knowledge of FDA Quality System Regulation (QSR) and medical device regulatory requirements.
• Experience supporting quality inspections, managing customer complaints, and creating quality documentation.
• Strong organizational, communication, and problem-solving skills with high attention to detail. Familiarity with quality management principles and systems in an ISO 9001 and ISO 13485 (medical device) company preferred, but not required
• Ability to work collaboratively within a team environment while maintaining individual accountability for tasks

Preferred

• ASQ certifications (CQE, CQA) or regulatory affairs certifications (RAC).
• Experience with electronic components, cable assemblies, and communication accessories.
• Familiarity with risk management (ISO 14971), validation processes, and statistical quality tools (SPC, Gage R&R, etc.).

Keywords: Quality Assurance, QA, Quality Control, Compliance, ISO 9001, ISO 13485, FDA, Quality System Regulation (QSR), Medical Devices, Electronics