Global Quality Assurance Engineer
Company 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:
- Primary - Review and process first part approvals for Customer New Product Development (NPD) initiatives, including development, review, and submission of all required supporting documentation. Work with Customer facilities as required to achieve acceptable outputs from manufacturing processes and to ensure all required process controls are in place.
- Secondary - Evaluate customer complaints to determine preliminary root cause and direct corrective actions as appropriate. Provide formal written evaluations summarizing findings for customers.
Requirements:
- BS in an Engineering discipline, Mechanical or Industrial Engineering are preferred.
- 3+ years of experience (or equivalent) in a Quality Engineering role.
- Familiarity with Quality tools and processes such as first article approval, FMEAs, control plans, process capability, and Gage R&R studies.
- Ability to read and interpret technical drawings, including understanding of GD&T.
- Familiarity with Minitab software is a plus.
- Must have the ability to quickly learn and understand new concepts.
- Knowledge of Customer product line desired.
- Ability to travel as required.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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