Quality Engineer

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.

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.  

• Contributes to team effort by accomplishing tasks as needed, and coordinating with other departments 

• Communicates effectively with Flexan’s employees and management.  

• Other duties as assigned 

• Demonstrates all of 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 

Minimum Qualifications:

• Bachelor of science from a four-year college or university in an engineering or science related field, Certified ISO 9001 Auditor or similar certification a plus.

• 5 years experience in quality environment, medical device experience preferred.  

• Thorough understanding of ISO 9001 Standards and Requirements. Minimum one year of experience with ISO9001 quality management system in a manufacturing environment.  

• Familiarity with PPAP, APQP and MSA.  

• Preferred experience with LEAN & Six Sigma manufacturing practices. 

• Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software).  SOLIDWORKS or CAD modeling software is a plus ​​​​​​

• Must be detail oriented, customer service oriented, focused and able to produce accurate and professional documents  

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.