Job Type
Full-time
Description
Quality EngineerFull-time | Permanent | On-site
Salaried | $85k - $105k
*We are not accepting candidates from third party agencies.About this Opportunity:The Quality Engineer supports product quality, process improvement, and compliance activities within a contract manufacturing environment focused on precision metal components for medical devices. This role is responsible for driving quality performance through nonconformance management, root cause analysis, CAPA, MRB support, process monitoring, and continuous improvement initiatives.
The QE will work closely with Manufacturing Engineering, Inspection, Production, Supplier Quality, and Operations to identify quality issues, interpret inspection and measurement data, support containment and corrective actions, and improve process stability. A strong understanding of CNC machining processes, dimensional inspection, GD&T, and CMM measurement data is preferred to support effective troubleshooting and data-driven decision making.
Responsibilities:- Own and support investigation and documentation of nonconformances in systems such as ETQ, including defect analysis, containment, root cause, corrective action, and effectiveness verification.
- Support timely MRB activities and complaint dispositions, including coordination with cross-functional teams, follow-up on actions, and documentation of decisions.
- Lead root cause analysis using tools such as 5 Whys, Fishbone, Pareto analysis, process mapping, and data-driven problem solving.
- Drive continuous improvement projects focused on defect reduction, rework reduction, process stability, inspection efficiency, and overall quality performance.
- Partner with Manufacturing Engineering and Production to troubleshoot CNC machining-related quality issues, including dimensional variation, process drift, tooling-related defects, setup issues, and repeat nonconformances.
- Review and interpret engineering drawings, specifications, GD&T requirements, inspection plans, and customer quality requirements.
- Analyze dimensional inspection results, including CMM reports, to identify trends, measurement concerns, process capability gaps, and potential root causes.
- Work with Inspection and CMM teams to support measurement data interpretation, inspection method reviews, and troubleshooting of questionable or inconsistent results.
- Support First Article Inspection, validation activities, process qualification, and capability studies through dimensional review, data analysis, and documentation.
- Support incoming inspection and supplier quality activities, including supplier issue investigation, SCAR support, and defect trend analysis.
- Own and execute CAPA and continuous improvement actions to improve process control and prevent recurrence of quality issues.
- Maintain and improve quality documentation, including procedures, work instructions, inspection checklists, control plans, and quality records.
- Support internal and external audits, including preparation, evidence gathering, audit response, and corrective action follow-up.
- Track, analyze, and report quality metrics such as defects, rework trends, yield, MRB aging, repeat issues, and process performance.
- Knowledge of process capability, GR&R, measurement system analysis, and statistical process control.
Requirements
- Bachelor's degree in Engineering, Manufacturing, Mechanical Engineering, Biomedical Engineering, or related technical field; equivalent technical experience may be considered.
- 3+ years of experience in Quality Engineering, Manufacturing Engineering, or related engineering role in a manufacturing environment.
- Strong understanding of engineering drawings, specifications, GD&T, and dimensional inspection methods.
- Experience supporting nonconformance management, MRB, CAPA, root cause analysis, and corrective action implementation.
- Working knowledge of CNC machining processes and common machining-related defects preferred.
- Ability to interpret inspection and measurement data, including CMM reports, dimensional results, and trend data.
- Strong problem-solving skills with the ability to connect measurement data to potential process, tooling, setup, material, or inspection method issues.
- Experience using data analysis tools such as Excel and/or Minitab to identify trends and support decision making.
- Strong communication skills and ability to work effectively with Manufacturing, Inspection, Engineering, Quality, and Operations teams.
- Ability to manage multiple priorities and drive actions to completion in a fast-paced manufacturing environment.
- Strong understanding of inspection planning, FAI requirements, validation support, and customer quality expectations.
- Experience leading continuous improvement, Kaizen, Lean, Six Sigma, or defect reduction projects.
Preferred Qualifications- Experience in medical device manufacturing or another regulated industry.
- Familiarity with ISO 13485, ISO 9001, and/or FDA 21 CFR Part 820 requirements.
- Hands-on experience with CNC machining, precision metal components, sheet metal, or metal fabrication processes.
- Experience reviewing CMM reports and working with inspection teams to troubleshoot measurement results.
- Experience with ETQ, Visual ERP, or similar quality/ERP systems.
