Associate Failure Analysis Engineer

Job#: 3032936

Job Description:
Job DescriptionAssociate Failure Analysis Engineer

Location: Acton, Massachusetts (Onsite)
Employment Type: Contract

Role Overview

The Associate Failure Analysis Engineer plays an integral role in the Quality Department as a hands-on engineering role conducting post-market investigations of FDA-approved medical devices. The position requires organization skills, attention to detail, the ability to work in cross-functional teams, and a drive to accomplish departmental and company goals.

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.
• Assist 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.
• Perform other duties as assigned.

Required Qualifications

Education: Bachelor's Degree in an engineering or scientific discipline, or equivalent experience.

Preferred Qualifications

• 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.

Work Environment

• Sitting 70%, Standing 30%
• Frequent lifting under 5lbs
• Occasional (less than 5% of time) handling (push/pull) up to 50lbs
• Ability to operate basic hand tools

Compensation & Benefits

The pay range for this position is between $51.00 and $52.00 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. Apex Systems offers a benefits package that includes medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid sick leave and other paid time off may vary by client location and applicable state law.

This employer is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Apex uses a virtual recruiter as part of the application process. Click for more details.

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Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Everforth Apex uses a virtual recruiter as part of the application process. Click for more details.

Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.