Associate Failure Analysis Engineer

Key Responsibilities

• Perform moderately complex tasks to ensure compliance with quality standards.
• Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.
• Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.
• Perform product testing and failure analysis.
• Review Lot Acceptance records and DHRs, create trend charts.
• Perform investigation triage and deep dive investigations to develop a hypothesis for failure.
• Collect and log quality data and trend results.
• Provide accountability for quality investigation and root cause analysis.
• Aid in gathering information during FDA and ISO 13485 inspections.
• Evaluate process flow by applying Lean Six Sigma methodology to streamline.
• Troubleshoot new failure modes.
• Evaluate process and engineering controls to improve safety and efficiency.
• Assist with other duties as assigned.

Required Qualifications

• Education: Bachelor’s Degree in an engineering or scientific discipline, or equivalent experience.
• Computer proficiency in MS office (specifically Excel).
• Electrical and mechanical background is preferred.
• Experience creating and analyzing charts in MS Excel is a plus.
• Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls is a plus.
• Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment is preferred.
• Preferred 2 years in a Quality-related function, working with QSR and/or ISO 13485.
• Effective verbal and technical writing skills.
• Excels at generating and maintaining organized and accurate records.

Compensation & Benefits

The pay range for this position is between $45.00 and $51.00 per hour. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and experience.

Alexander Technologies Group is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Alexander Technologies Group will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.