Supplier Quality Engineer (Medical Device)

Job Posting Start Date 03-29-2024 Job Posting End Date Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Supplier Selection

• -Select the suitable supplier with jointed-effort of sourcing on aspects of quality, capability, pricing, delivery, environment, society regulation, etc. against customer requirements.
Supplier Qualification
• -Implement the new supplier qualification thru the process of capability matching, supplier risk assessment, supplier self-assessment, onsite qualification audit, qualification database management.
VEA (Value-Added Engineering Activity)
• -Understand customer drawing, specification to feedback value-added engineering proposal to customer and supplier for optimization of supplier manufacturing process or products.
Material (Component) Qualification
• -Implement PPAP (FAI). PPAP include FAI, Material Certificates, Quality/Process Control Plan, FMEA, MSA, Process Parameter Sheet, RoHS compliance, Reliability Test, COC, etc.
Pilot Run Tracking
• -Track the new qualified parts quality performance to ensure meet the customer quality requirements in pilot run phase. Drive supplier corrective action from supplier in Pilot Runs (1-3 lots) and smoothly transfer the pilot run to mass production.
Hot Issue Solution and Trouble Shooting
• - Working as SME (Subject Matter Expert) to help on Supplier Quality hot issue and trouble shooting.
Holds up Maintenance Audit
• -helps on the annual maintenance audit for existing suppliers with SQE.
Holds up Supplier CIP (Continuous Improvement Program)
• - Helps supplier to use the quality tools to improve manufacturing process and product quality.
ECO/ECN/SCR implementation
• -Handle with ECO/ECN/SCR from customer, follow up the status in case that PPAP/FAI is required prior to production.
• Performs quality audits on suppliers to assure products and services meet International Organization for Standards (ISO) and regulatory standards.
• Forms a good relationship with the purchasing engineer and the supplier system in order to maintain a strong system and supplier relationships for the organization in which they work.
• Provides cross functional help to select, approve and develop suppliers to meet customer and business needs.
• Ensures supplier selection, development, approval and rejection according to SJM vendor guidelines and requirements.
• Drives full assessment for effectiveness of supplier process control plans, measures and activities.
• Uses statistical techniques and professional judgment to research data for process improvement.
• Develops and guides execution of process validations and tests; explores resulting data and document results (protocols/reports).
• Constructs Design of Experiments to characterize supplier processes and/or sets on root cause.
• Develops and implements procedures for new and/or improved supplier processes.
• Provides engineering help to Receiving Inspection including statistical research, measurement systems exploring, Gage R&R studies and inspection procedures.
• Participates in Material Review Board resolutions on supplier provided parts and services
• Participates in supplier Quality System Improvement Plans.
• Guides the Supplier Requests for Change process.
• Performs supplier Quality System audits.
• Performs corrective and preventive actions with suppliers.
• Performs research of non-conformances and supplier performance for key performance
• Rate and track supplier’s performance and drive supplier continuous improvement.
• Establish and maintain supplier management processes and tools.

• 3 or more years as a Supplier Quality Engineer in a regulated industry (Medical Device, Pharmaceutical, Aerospace, Nuclear, etc)
• Audit certification by an accrediting body such as ASQ or BSI is preferred
• Knowledge of injection molding, tool qualification, and machining processes or related experience is preferred
• Knowledge of statistical methods and their application to a manufacturing process is preferred
• Must be a motivated and organized multi-tasker who requires minimal supervision to complete assignments

• Full range of medical benefits, dental, vision
• Life Insurance
• Matching 401K
• PTO
• Tuition Reimbursement
• Employee discounts at local retailers

Quality Relocation: Eligible for domestic relocation only No Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).