- 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.
Requirements
Minimum 4 to 5 years of experience working in a regulated industry. Experience in CSV Process Validation and Equipment Qualification. Experience in Risk Management Documents (PFMEA). Bachelor Degree in Engineering Completed.
What are the top 3 things you are looking for in a candidates experience:
- 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
Willing to work 100% onsite.
Willing to work full time On-Site.