Quality Engineer Assistant

About the role

The Quality Engineer Assistant supports engineering, quality, production and technical teams at the campus to collect and provide information needed to achieve quality levels, customer satisfaction and financial goals. Working under the direction of the Quality/NPI manager, the assistant helps senior quality engineers on projects related to medical device development and production.

Key responsibilities

• Follow GMP and SOPs to ensure compliance with FDA and other regulations.
• Prepare and translate technical documents, component specifications, and item master records.
• Assist in drafting and executing Test Method Validation (TMV) protocols and support equipment verification.
• Participate in FMEA, risk analysis, and new product development activities.
• Collect process data for TMVs, support training, validation and transfer activities.
• Perform first‑article inspections, manage quality cage inventories, and generate inspection reports.
• Initiate and track non‑conformances (NC) and complaints, supporting CAPA investigations.
• Maintain organized work area, accurate records and documentation, and attend required trainings.

Required profile

• Relevant engineering or scientific education (e.g., biomedical, mechanical, or industrial engineering).
• Ability to work Monday‑Friday, 8 am‑5 pm, with occasional remote work as needed.
• Familiarity with FDA regulations and GMP practices.
• Strong attention to detail and ability to maintain precise documentation.

Required skills

• Good Manufacturing Practices (GMP) compliance
• FDA regulatory knowledge
• Failure Mode and Effects Analysis (FMEA)
• Test Method Validation (TMV) procedures
• Document preparation and translation
• Component specification and Item Master creation