Quality Engineer

 ***This is not a remote position***

Position Summary

The Quality Engineer is responsible for supporting, maintaining, and improving an ISO 13485–compliant Quality Management System (QMS). This role ensures manufactured products meet all applicable regulatory, customer, and internal requirements through effective process control, risk-based decision-making, and cross-functional collaboration. The position combines hands-on manufacturing quality support with ownership of key quality system processes.

Essential Responsibilities

Quality Management System (ISO 13485 / FDA 21 CFR Part 820)

• Maintain and improve the effectiveness of the ISO 13485–certified QMS.
• Ensure ongoing compliance with applicable FDA 21 CFR Part 820 requirements.
• Support internal audits, supplier audits, and external audits (certification, customer, and regulatory).
• Review, revise, and improve SOPs, Work Instructions, and quality records to ensure clarity, compliance, and effectiveness.
• Provide data, metrics, and objective evidence to support Management Review.

Nonconformance, CAPA, and Continuous Improvement

• Monitor, analyze, and trend internal and external nonconformances.
• Lead root cause investigations using structured problem-solving methodologies.
• Initiate, manage, and verify the effectiveness of corrective and preventive actions (CAPA).
• Facilitate regular CAPA review meetings and ensure timely closure.
• Drive continuous improvement initiatives using quality data, risk analysis, and performance metrics.

Manufacturing & Product Quality Support

• Ensure inspection criteria and acceptance requirements are clearly defined and accurately reflected on engineering drawings, routers, and inspection plans.
• Support Engineering Change Orders (ECOs), Engineering Change Requests (ECRs), and Document Change Requests (DCRs).
• Partner with Manufacturing and Engineering to resolve quality issues and improve process capability.
• Support first article inspections, process validations, and change impact assessments as required.

Measurement Systems & Metrology

• Ensure inspection and measurement methods are appropriate, repeatable, and reliable.
• Lead or support GR&R studies and measurement system analyses (MSA).
• Maintain confidence in inspection results through proper use of calibrated and verified metrology equipment.
• Train Quality and Production personnel on inspection techniques, GD&T interpretation, and metrology best practices.

Supplier Quality

• Support supplier qualification, monitoring, and re-evaluation activities.
• Lead or approve supplier audits and supplier corrective actions.
• Analyze supplier performance data and work with suppliers to drive improvement.

Training & Communication

• Provide quality-related training to internal personnel as required.
• Communicate quality trends, risks, and improvement opportunities to cross-functional teams.
• Act as a quality liaison between Manufacturing, Engineering, Supply Chain, and Management.

Job Experience Required

• 5+ years in inspection and quality assurance (medical device, aerospace, automotive, or machining preferred)
• 3+ years in document control within FDA-regulated environments and knowledge of ISO 13485
• Demonstrated success improving quality systems and reducing nonconformance's
• Strong working knowledge of advanced metrology tools: Micro-Vu, Keyence, Optical Comparators, calipers, micrometers, gage pins, and more
• Proficiency in MS Office Suite, Adobe Visio, PowerPoint, and advanced Excel (PivotTables, VLOOKUP, Data Analysis)
• Independent, self-driven leader capable of managing projects, timelines, and control plans
• Excellent verbal and written communication—able to lead training, write reports, and engage stakeholders effectively

 Work Environment 

• Split between office and manufacturing floor; observation, collaboration, and inspection are part of the daily rhythm
• Physical flexibility required: occasional lifting (5–10 lbs.), standing/walking for data gathering
• Minimal travel
• On Site position, not remote

Scheduled Hours

• Monday thru Thursday (7:30am - 5pm)
• Friday (7:30am - 11:30am)

Education 

• Bachelor's degree in science or engineering from an accredited College or University or equivalent work experience

 Why work for us:  

• Excellent medical, dental and vision benefits after 60 days; 100% paid for employees and 75% paid for dependents. 
• Paid vacation, PTO and 8 paid holidays 
• Annual performance bonus
• Profit sharing and matching 401K