Quality Specialist - Medical Devices

The Associate Failure Analysis Engineer plays a key role within the Quality Department, focusing on post-market investigations of FDA-approved medical devices. This hands-on engineering position requires strong organizational skills, attention to detail, and the ability to collaborate across functions to achieve departmental and company objectives.

• Conduct product testing and failure analysis.
• Perform investigations, including triage and deep dives, to develop hypotheses for failures.
• Partner with quality assurance engineers to ensure effective inspection and testing procedures.
• Generate, review, and maintain quality records (training, audits, NCR, CAPA).
• Review lot acceptance records and DHRs, create trend charts, and collect quality data.
• Drive root cause analysis and accountability for quality investigations.
• Support FDA and ISO 13485 inspections by gathering information.
• Apply Lean Six Sigma methodology to evaluate and streamline process flows.
• Troubleshoot new failure modes and assess engineering controls for safety and efficiency.
• Perform other duties as assigned.

• Bachelor’s degree in engineering or a scientific discipline, or equivalent experience.
• 2+ years in a quality-related function, preferably in a regulated industry (medical devices).
• Strong background in electrical and mechanical systems preferred.
• Proficiency in MS Office, especially Excel (charting and data analysis).
• Knowledge of Six Sigma, Lean, SPC, ASQ, and ISO process controls is a plus.
• Effective verbal communication and excellent technical writing skills.
• Demonstrated ability to maintain organized and accurate records.

• Frequent lifting up to 5 lbs; occasional handling up to 50 lbs.
• Ability to operate basic hand tools.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.