What are the responsibilities and job description for the Quality Engineer - Medical Devices position at Planet Pharma?
Job ID: 613484
Our client, a leading Medical Device company, is seeking an experienced junior level Quality Engineer - this role will assist with supporting work from the test team which entails prioritizing, reviewing, and providing feedback and direction on test plans and reports. See below for other details!
***Please Note: This position requires someone to be onsite 3 days/week - Only apply to this role if you are able to work onsite in North Haven, CT***
Responsibilities:
- Providing guidance on appropriate testing methods, sample sizes, and acceptance criteria, and then ensuring the report acceptance criteria satisfies the design intent.
- Engineering Report reviews, challenging the completeness and test results to ensure design requirements are satisfied through sufficient test evidence
- Statistical analyses & tools
- Understanding of complex systems operation and software controlled devices
- 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.
Requirements:
Bachelor's Degree and 2 years of work experience within the medical device (or highly regulated) industry