Quality Engineer Jobs

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 all engineering documentation including new project reviews, design review records, and drawings.
• Communicates effectively with Flexan’s employees and management.
• 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.
• Other duties as assigned
• 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.
• Works with process team to identify quality-related equipment, testing, and resource needs, and communicates needs to management.
• Supports the process team and communicates critical path quality items for product commercialization with all relevant departments.
• Contributes to team effort by accomplishing tasks as needed, and coordinating with other departments
• 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. 

• We embrace the choice to work here
• We operate with transparency, ethics, and integrity
• We embrace the rigor to be safety and quality driven in all we do
• Demonstrates all of Flexan’s corporate values:
• We have an engaged culture
• We consistently meet our expectations

Minimum Qualifications:

• Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software). SOLIDWORKS or CAD modeling software is a plus
• Thorough understanding of ISO 9001 Standards and Requirements. Minimum one year of experience with ISO9001 quality management system in a manufacturing environment.
• Preferred experience with LEAN & Six Sigma manufacturing practices.
• Familiarity with PPAP, APQP and MSA.
• 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.
• Must be detail oriented, customer service oriented, focused and able to produce accurate and professional documents
• 5 years experience in quality environment, medical device experience preferred.

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.

Powered by JazzHR

KpoZKvEmG0