Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities:

• Looking for a senior operations quality engineer for six months from the beginning of June. The scope of work for this role is to support the current senior operations quality engineer on a product transfer project from another site to this facility. Specifically, I'm looking for a person who can,
• Review risk management files (pFMEA).
• Review process validation protocols and reports.
• Draft/update the master validation plan.
• Review manufacturing process instructions.
• Draft quality inspection procedures.
• Review equipment introduction, calibration, and PM records.

Requirements:

• Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or related field) or equivalent experience.
• 5+ years of quality engineering experience in a medical device manufacturing environment (Class II preferred).
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971 (Risk Management), and ISO 14644 (Cleanrooms).
• Hands-on experience with CAPA, NCMR investigations, root cause analysis, and statistical process control (SPC).
• Proficiency in Process Validation (IQ, OQ, PQ), Gage R&R, and AQL sampling plans.
• Ability to interpret engineering drawings, GD&T, and work with metrology tools (calipers, micrometers, CMM).
• Prior BMRAM and Propel experience is a plus.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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