What are the responsibilities and job description for the Quality Engineer position at Katalyst Healthcares & Life Sciences?
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:
- BS Engineering and 2 years of experience.
- Drawing and Specification reviews.
- Manufacturing Process Control Plan reviews.
- Measurement System Analysis (MSA), Test Method Validation (TMV) reviews.
- Manufacturing process validation reviews.
- Manufacturing process capability assessment.
- Manufacturing Experience in a highly regulated environment.
- Risk Management- Medical.
Requirements:
- BS Engineering (EE preferred) and 2 years of experience.
- Design History File Audit and Management.
- Test Cases/Protocols/Report review and approve.
- Drawing and specification reviews.
- Design Control in a highly regulated industry.
- Hardware Verification and Validation.
- Testing Methodologies.
Additional Information
All your information will be kept confidential according to EEO guidelines.
