Quality Engineer

• 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:

• Quality Engineer w/ Design Quality Engineering experience, product quality support, design verification & Risk Management (ISO 14971) , Failure Assessment (FMEA) – MUST HAVE Medical Device experience.
• Quality Engineer will be a part of the clients' Diabetes Post-Market Quality Engineering team.
• This individual will primarily support quality deliverables for design changes, second sourcing and manufacturing improvement projects.
• This individual will also quality deliverables such as technical reviews, design assessments, design verification plans and reports and maintenance of risk management documentation for on-market Diabetes devices.
• This individual should be a good collaborator, able to take direction from other technical team members / PMO, and split time between several projects and teams.

Responsibilities:

• May include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Requirements:

• Bachelor's in engineering, science or technology discipline.
• Years' Experience Required: 4-10 years preferred.
• Design Quality Engineering experience.
• Highly prefer product quality support or design verification experience.
• Risk Management / Failure Assessment experience.

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