Associate Failure Analysis Engineer – Medical Devices

Apex Systems; Acton (MA); Hybrid; USD 94.000 - 106.000; Teilzeit

Benefits dieser Stelle

Medical coverage

Dental coverage

Vision coverage

401K plan

Zusammenfassung

Apex Systems in Acton, MA is seeking an Associate Failure Analysis Engineer to perform post-market investigations of FDA-approved medical devices. The role focuses on quality records, failure analysis, and cross-functional collaboration in a regulated environment.

Responsibilities include trend analysis, investigation triage, CAPA, NCR processing, and applying Lean Six Sigma to improve safety and efficiency.

Qualifikationen

• Bachelor's degree in engineering or science or equivalent experience.
• Experience creating and analyzing charts in MS Excel is a plus.
• Knowledge of Six Sigma, Lean, SPC, ASQ and ISO process controls is a plus.
• Experience in a regulated medical device environment is preferred.

Aufgaben

• Perform moderately complex tasks to ensure quality standards compliance.
• Generate, review and maintain Quality records (training, audits, NCR, CAPA).
• Perform product testing and failure analysis; triage investigations and develop hypotheses.
• Review DHRs, create trend charts; log quality data and trend results.
• Support FDA/ISO inspections and apply Lean Six Sigma to improve processes.

Kenntnisse

Quality systems knowledge

Attention to detail

Cross-functional teamwork

Verbal and technical writing

Ausbildung

Bachelor's Degree in engineering or scientific discipline

Tools

Excel

Jobbeschreibung

Apex Systems in Acton, MA is seeking an Associate Failure Analysis Engineer to perform post-market investigations of FDA-approved medical devices. The role focuses on quality records, failure analysis, and cross-functional collaboration in a regulated environment.

Responsibilities include trend analysis, investigation triage, CAPA, NCR processing, and applying Lean Six Sigma to improve safety and efficiency.