Quality Engineer - Medical Device

Intellectt Inc; Utah; On-site; USD 75,000 - 105,000; Full time

Job summary

Intellectt Inc. in Utah seeks a Quality Engineer with strong medical device manufacturing QA experience to strengthen process controls and CAPA programs.

You will lead root cause investigations, drive PFMEA and control plans, and collaborate with cross-functional teams to improve product quality and manufacturing processes in a regulated environment.

Qualifications

• Experience in medical device QA and manufacturing.
• Familiarity with FDA and ISO 13485 requirements.
• Ability to perform root cause analysis and CAPA.
• Strong statistical analysis skills (Minitab preferred).

Responsibilities

• Lead RCA and CAPA to prevent recurrence.
• Improve process controls and PFMEA.
• Address plastics and injection molding quality issues.
• Conduct statistical analyses using Minitab.
• Develop and improve PFMEAs and control plans.
• Ensure compliance with FDA regulations and ISO 13485.
• Collaborate with cross-functional teams to raise quality.

Skills

Quality engineering

RCA & CAPA

SPC & process capability

PFMEA & Control Plans

Injection molding

Labeling quality

Minitab

FDA & ISO 13485

Job description

We are looking for a Quality Engineer with strong experience in medical device manufacturing quality, root cause investigations, corrective and preventive actions (CAPA), and continuous process improvement. The ideal candidate should be capable of identifying recurring quality issues, implementing sustainable preventive measures, and strengthening manufacturing process controls.

Key Responsibilities:

• Lead root cause analysis and CAPA activities to address manufacturing quality issues and prevent recurrence.
• Drive process controls, process capability improvements, and defect prevention initiatives.
• Investigate assembly, labeling, plastics, and injection molding-related quality issues.
• Perform statistical analysis and quality investigations using Minitab.
• Develop and improve PFMEAs, control plans, and manufacturing quality procedures.
• Support compliance with FDA regulations and ISO 13485 quality management system requirements.
• Identify opportunities for continuous improvement and implement effective corrective and preventive measures.
• Work with cross-functional teams to improve product quality, manufacturing processes, and overall quality performance.

Required Skills:

• Medical device manufacturing quality engineering
• Root Cause Analysis (RCA) and CAPA
• Statistical Process Control (SPC) and process capability analysis
• PFMEA and Control Plans
• Plastics manufacturing and injection molding
• Assembly and labeling quality
• Minitab
• FDA and ISO 13485 compliance

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.