Quality Engineer

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.
Requisitos:
Duties/Responsibilities: - Experience reviewing and approving validation test plans, reports, and deviations
- Capable of performing statistical analysis to support validations and product release
- Knowledgeable of medical devices manufacturing regulations
- Experience in CSV
- Experience in medical device industry
- Experience in Process Validation and Equipment qualification
- Experience in risk management documents (e.g. pFMEA)

Education/Experience:
- Availability for 1st, 2nd and 3rd shift (Work Shift determined during interview)
- Bachelor's degree in engineering with 3 or more years of experience.