What are the responsibilities and job description for the Medical Device Quality Engineer-Junior position at Master Compliance Inc?
Job Details
Job Title: Quality Engineer-Medical Device
Job Location: Lafayette, Colorado (On-site)
Type: W2 Contract
Duration: Position is 6 months from the start date of the candidate
Job Description:
Responsibilities may include the following and other duties may be assigned:
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
Technical skills that are required for the role:
Manufacturing experience in a highly regulated industry
risk management in a highly regulated industry
Critical thinking
Education Required: Bachelor's degree in Engineering, Science, or technical field required
Years Experience Required: Minimum of 2 years of highly regulated industry experience.
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. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
