Job Title: Quality Engineer Medical Device
Duration: 12 Months
Location: Remote USA
Employment Type: W2 Contract
Pay Rate: $38/hr(DOE) W2
Industry: Medical Devices / Life Sciences
Job Summary:
We are seeking a Quality Engineer to support product testing, failure analysis, and laboratory investigations for returned medical products. The ideal candidate will have hands-on experience investigating product failures, performing laboratory testing, identifying failure modes, and determining potential root causes.
The engineer will collaborate with Quality, R&D, Manufacturing, and Engineering teams to investigate product issues, document technical findings, and support CAPA, nonconformance, and corrective-action activities.
Key Responsibilities:
Conduct investigations of returned medical products/devices and identify potential failure modes.
Perform hands-on laboratory testing, product evaluation, troubleshooting, and functional testing.
Analyze test results, product performance data, and failure information to determine potential root causes.
Perform failure analysis and root cause investigations.
Develop and execute test methods, protocols, and investigation plans.
Support CAPA, NCR/nonconformance, complaint, and quality investigations.
Prepare detailed investigation reports documenting test methods, results, observations, and conclusions.
Collaborate with Quality, R&D, Manufacturing, and Engineering teams to resolve product-quality issues.
Support corrective and preventive actions and continuous improvement initiatives.
Ensure investigation activities and documentation comply with applicable quality procedures.
Job Requirements:
5+ years of experience in Quality Engineering, Product Testing, Failure Analysis, Reliability Engineering, Laboratory Engineering, or a related field.
Hands-on experience with product failure investigations and failure-mode analysis.
Experience performing laboratory testing, product evaluation, troubleshooting, and failure reproduction.
Strong knowledge of Root Cause Analysis (RCA) and structured problem-solving methodologies.
Experience with CAPA, NCR/nonconformance, corrective actions, and quality investigations.
Experience developing and executing test methods and laboratory protocols.
Strong technical documentation and report-writing skills.
Ability to analyze test data and translate findings into clear technical conclusions.
Strong problem-solving and analytical skills.
Experience collaborating with Quality, R&D, Manufacturing, and Engineering teams.
Preferred Qualifications
Experience in medical devices, pharmaceuticals, biotechnology, life sciences, or another regulated industry.
Experience with returned product or customer complaint investigations.
Knowledge of FMEA, 8D, 5 Whys, Fishbone/Ishikawa, or other root-cause methodologies.
Familiarity with FDA Quality System requirements and/or ISO 13485.
ASQ CQE/CQA or Lean Six Sigma certification is a plus.
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, or a related discipline.
Candidate Profile
Ideal candidates will come from backgrounds such as:
Quality Engineer
Failure Analysis Engineer
Reliability Engineer
Product Engineer
Test Engineer
Complaint Investigation Engineer
Laboratory Engineer
Candidates with strong hands-on experience in failure investigation, product testing, laboratory evaluation, root cause analysis, CAPA, and medical-device quality are encouraged to apply.
Interested candidates should share an updated resume along with recent client references. this is too big give in medium size