Senior Quality Engineer

at  Flexan

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 Senior Quality Engineer assures products, processes, and quality records conform to quality standards and establish compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by safety and meeting business needs. Lead on-time completion of Quality Assurance (QA) engineering deliverables within Manufacturing and New Product Introduction (NPI).

EDUCATION AND EXPERIENCE

• Minimum of 3 years of Quality experience
• Detailed knowledge of FDA 21 CFR 820, ISO 13485 and GMP.
• Robust functional knowledge of Failure Mode Effects Analysis (FMEA) and Production Part Approval Process (PPAP)

REQUIRED SKILLS/ATTITUDES

• Moderate statistical/data analysis and report writing skills
• Need to be competent in using Microsoft Office applications and Mini-Tab is an advantage
• Organization and time management skills are essential.
• Creativity, verbal and written communication skills, analytical and problem-solving ability
• Effectively represent Flexan during customer projects and related activities.
• Strong attention to detail • Able to multitask • Able to sit or stand for extended periods
• Must be able to lift 20 pounds.
• Willing and able to problem solve when something is not working right
• Good work ethic (comes to work and returns from lunch and breaks on time, works hard to reach work standards, tries to minimize waste)
• Team player that gets along well with others (respectful of supervisors and co-workers, helps others by helping and ideas when appropriate)
• Is proactive in identifying potential problems or opportunities to increase productivity and quality, decrease waste and improve morale.
  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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• Process QA requests, ensuring timely responses are provided in alignment with quality goals and customer expectations.
• Lead meetings and communications for QA system information, concerns, and updates.
• Specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, and administrative applications.
• Work with Production on Continuous Improvement (CI) projects.
• Interpret and comply with Flexan’s quality assurance standards.
• Analyze and investigate product complaints or reported internal or external quality issues to ensure closure in accordance with company guidelines and external regulatory and customer requirements.
• Must be able to work independently with minimal supervision.
• Conversant with current Flexan NPI/CAPA/Validation procedures.
• Participate in internal and external audits as needed.
• Cooperate with and demonstrate professional conduct with coworkers and managers.
• Meet Flexan standards for quality and productivity. FMI, Inc. Confidential Internal Document Only
• Complete various required paperwork and documentation error free while following Flexan’s Good Documentation Practices.
• Follow all procedures for cleanroom operation, cleanroom attire, and contamination control.
• Follow all Flexan procedures for traceability, line clearance, process control, safety, and housekeeping.
• Demonstrates all 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