Early Career Biomedical Engineer

Position Summary

The Associate Quality Engineer is an early career position focused on supporting quality assurance, regulatory compliance, and continuous improvement initiatives throughout the product lifecycle. Working closely with cross-functional teams in R&D, Manufacturing, and Regulatory Affairs, you will learn to implement quality tools, investigate non-conformances, and maintain compliance with FDA and ISO standards.

Key Responsibilities

• Quality Assurance & Compliance: Support the maintenance of the Quality Management System (QMS) in accordance with FDA 21 CFR Part 820 and ISO 13485 standards.
• Documentation & Review: Review and update Device History Records (DHR), Standard Operating Procedures (SOPs), and quality inspection logs to ensure complete traceability.
• Testing & Inspection: Assist in developing inspection plans and conducting test methods for raw materials, in-process components, and finished medical devices.
• CAPA & Non-Conformance: Participate in investigating material non-conformances and Root Cause Analysis (RCA); assist in documenting Corrective and Preventive Actions (CAPA).
• Data Analysis: Collect and analyze quality performance data utilizing basic statistical techniques to identify trends and areas for process improvement.
• Validation Support: Assist higher-level quality and manufacturing engineers with Equipment Qualification (IQ/OQ/PQ) and process validation protocols.

Qualifications & Skills

• Education: Bachelor’s degree in Biomedical Engineering, Bioengineering, Mechanical Engineering, or a closely related technical discipline.
• Experience: 0–2 years of experience. Prior internship, co-op, or academic project work within a regulated industry (Medical Device, Pharma, or Biotech) is highly preferred.

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Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

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The Company will consider qualified applicants with arrest and conviction records.