Supplier Quality Engineer-Medical Device

Supplier Quality Engineer – Medical Device

Join to apply for the Supplier Quality Engineer – Medical Device role at Hi Arc .

HiArc engineers and manufactures complex medical technologies with a focus on client-centered solutions. We fuse design, engineering, and manufacturing into a seamless, collaborative process, operating as an extension of our clients' teams to de-risk processes and accelerate time to market.

• Perform supplier evaluation audits, supplier support and supplier advanced quality planning (AQP).
• Manage supplier performance by monitoring quality, delivery, and cost metrics and developing corrective action plans when appropriate.
• Review potential suppliers for acceptability to ASL and support their evaluation/classification.
• Work with suppliers to support business requirements, including NCMR’s and SCAR’s.
• Facilitate root cause analysis, corrective actions, and recommend processes, procedures, and equipment.
• Audit suppliers for root cause analysis and verification of correction actions.
• Interact with suppliers to ensure timely NCMR’s and SCAR’s, including effectiveness and verification.
• Collaborate with Design and Manufacturing Engineering teams to define process parameters that meet product and process requirements.
• Support complete and accurate documentation of inspection results per regulations, product specifications, Control Plans, Part Approval Process or product warrant submissions.
• Review supplier manufacturing processes, collaborate on process improvement and value enhancement opportunities.
• Promote continuous improvement techniques such as Lean, Poka-Yoke, Measurement System Analysis, and PFMEA.
• Lead identification and development of suppliers across technology, performance, quality, cost, logistics, and delivery.

• Bachelor’s Degree in Engineering (Electrical, Mechanical) with 5 years of related experience in a manufacturing environment;
  Electrical Engineering preferred.
• Proficient in the competencies listed above or equivalent experience.
• Strong organizational, interpersonal, analytical, communication and presentation skills.
• Lead Auditor Certification ISO 9001 and 13485 preferred.
• Lean Green belt preferred.
• Innovative & Creative.
• Medical Device Industry experience preferred.
• Proficient with Windows OS and Microsoft Office.
• Experience with Minitab.
• Experience working with suppliers of PCBAs and other electrical components highly preferred.
• Requires daily onsite presence.

• Supplier Audit
• Quality Systems, Standards, and Methodology
• Continuous Improvement:
  Lean principles, 5S, PAFMEA, Visual Factory
• Problem Analysis & Solving
• Product Design & Development
• Statistical Process Control (SPC)
• Human Factors, Ergonomics, and Safety
• Enterprise-wide Systems Integration (PLM, MRP, MES, ERP, etc.)
• Failure Analysis
• Engineering specifications – Schematics, Layouts, Prints

• Most locations offer a 9/80 schedule.
• Competitive compensation & 401(k) program.
• Robust medical, dental, vision, & disability coverage with wellness discounts.
• Basic Life Insurance and Additional Life & AD&D Insurances available.
• Flexible Vacation & PTO.
• Paid Parental Leave.
• Generous Employee Referral Program.
• Voluntary Benefits:
  Long Term Care, Legal, Identity Theft, Pet Insurance, etc.
• Voluntary Tricare Supplement available for military retirees.

Mid-Senior level

Full-time

Quality Assurance

Medical Equipment Manufacturing

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer to all protected groups, including protected veterans and individuals with disabilities.

If you encounter issues with your application, please email Talen***.