Quality Engineer

Quality Engineer – Medical Device Manufacturing

The information below covers the role requirements, expected candidate experience, and accompanying qualifications.

Location: Libertyville Il

Hire Type: Contract / Contract-to-Hire

Compensation:- $45-$65

Schedule: Full-Time | Onsite

Overview

We are seeking a Quality Engineer to support quality engineering activities within a regulated medical device manufacturing environment. This position will work closely with Manufacturing, Engineering, Metrology, and Operations to ensure products and processes meet quality, regulatory, and customer requirements.

The ideal candidate will have strong experience with ISO 13485, ISO 14971, PFMEA, CAPA, and quality investigations within medical device manufacturing. Experience supporting metrology and measurement systems is important, while experience with plastic injection molding processes is highly preferred.

Key Responsibilities

Support and maintain quality systems in compliance with ISO 13485 and applicable medical device regulatory requirements.

Apply ISO 14971 risk management principles to manufacturing processes, product quality, and continuous improvement activities.

Develop, maintain, and facilitate PFMEAs, risk assessments, control plans, and related quality documentation.

Lead and support CAPA activities, including investigation, root cause analysis, corrective/preventive actions, implementation, and effectiveness checks.

Investigate product and process nonconformances, deviations, manufacturing defects, and recurring quality issues.

Utilize structured root cause analysis and problem-solving methodologies to identify and eliminate sources of quality issues.

Partner with Manufacturing and Engineering teams to improve process capability, reduce defects, and drive continuous improvement.

Support metrology and inspection activities, including measurement methods, inspection equipment, calibration requirements, and measurement system troubleshooting.

Assist with the development and improvement of inspection methods, specifications, and acceptance criteria.

Support validation, qualification, and process-change activities as required.

Review quality data and manufacturing trends to identify potential risks and opportunities for improvement.

Participate in internal and external audits and support responses to audit findings.

Provide quality engineering support for new product introductions, process changes, equipment changes, and manufacturing transfers.

Support supplier and customer quality activities as needed.

Qualifications

Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical discipline preferred.

Experience working in a medical device or similarly regulated manufacturing environment.

Working knowledge of ISO 13485 and ISO 14971.

Hands-on experience developing or maintaining PFMEAs.

Strong experience with CAPA, nonconformance investigations, root cause analysis, and corrective actions.

Experience supporting metrology, dimensional inspection, measurement systems, or calibration activities.

Ability to read and interpret engineering drawings, specifications, tolerances, and quality requirements.

Strong analytical, problem-solving, documentation, and cross-functional communication skills.

Experience with statistical quality tools, process capability, SPC, MSA, or Gage R&R is preferred.

Injection molding / plastic manufacturing experience is a strong plus, particularly within medical device manufacturing. xhyhwjd

Preferred Experience

Candidates with experience supporting injection molding processes, molded medical device components, tooling, process validation, dimensional inspection, and metrology laboratories will be especially well suited for this position.