- Posted: 10 days ago
Flexan is a global strategic contract manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies and devices designed to meet the critical requirements of Class I, Class II and Class III medical devices, as well as custom compounding and molding for precision parts.
JOB DESCRIPTION: The Quality Engineer is responsible for the full range of QA/RA system support from development activities through managing the handoff of qualified processes to production and ensuring that commercialization activities are successful. This position is responsible for the proper documentation, reporting, and data analysis as it relates to quality reporting, medical device validation, and customer quality correspondence.
KEY ROLE AND RESPONSIBILITIES:
Manages Feedback Management and CAPA activities through CAPA Review Board closure. Partners with internal customers to facilitate closure of product, process, and system related CAPA’s.
Co-Owns the New Product Introduction (NPI) process by managing all required documentation including, customer documents, NPI “checklist” items, validation protocols/reports, statistical analysis, and compliance to all relevant ISO documents.
Supports the process team and communicates critical path quality items for product commercialization with all relevant departments.
Works with process team to identify quality-related equipment, testing, and resource needs, and communicates needs to management.
Manages all engineering documentation including new project reviews, design review records, and drawings.
Analyzes data/test results and integrates information into process and manufacturing continuous improvements.
Assists the Quality and Manufacturing departments in resolving validation and non-conformance issues, as needed.
Performs other duties as assigned by the Quality Manager.
Contributes to team effort by accomplishing tasks as needed, and coordinating with other departments
Communicates effectively with Flexan’s employees and management.
Demonstrates all of the Flexan’ s corporate values:
- We have an engaged culture
- We embrace the rigor to be safety and quality driven in all we do
- We embrace the choice to work here
- We operate with transparency, ethics, and integrity
- We consistently meet our expectations
Bachelor of science from a four-year college or university in an engineering or science related field
5-10 years' experience in quality environment, medical device experience preferred.
Must be motivated and creative, work well under pressure and operate effectively in a fast-paced team environment.
Must meet internal deadlines and customer due dates
Must have excellent interpersonal skills and ability to communicate needs and demands in an effective manner.
Must be detail oriented, focused and able to produce accurate and professional documents
Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software). SOLIDWORKS or CAD modeling software is a plus
It is the policy of Flexan, LLC to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Flexan will provide reasonable accommodations for qualified individuals with disabilities.
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AddressSalt Lake City, UT
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