Supplier Quality Engineer-Medical Device jobs in United States
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HiArc · 1 week ago

Supplier Quality Engineer-Medical Device

HiArc is a company that engineers and manufactures complex medical technologies with a focus on client-centered solutions. The Senior Supplier Quality Engineer will oversee supplier performance, implement best practices for quality assurance, and ensure compliance with customer-specific requirements to enhance product quality and minimize costs.

Health CareInformation TechnologyManufacturingMedical
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H1B Sponsor Likelynote

Responsibilities

Perform Supplier evaluation audits, supplier support and supplier advanced quality planning (AQP)
Manage supplier performance by monitoring of quality, delivery, and cost metrics and developing corrective action plans when appropriate
Review potential suppliers for acceptability to ASL
Support the evaluation/classification of suppliers
Work with the supplier directly to support business requirements: Non-Conforming Material Reports (NCMR’s) and Supplier Corrective Actions (SCAR’s)
Facilitate root cause analysis and corrective actions of supplier quality issues, Identify and recommends processes, procedures, and equipment
Audit suppliers for root cause analysis and verification of correction actions of supplier quality issues
Interact with Supplier to ensure timely Non-Conforming Material Reports (NCMR’s) and Supplier Corrective Actions (SCAR’s), including effectiveness and verification
Work with Design and Manufacturing Engineering teams to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements
Supporting complete and accurate documentation of inspection results as defined by regulations, product specifications or Control Plans, Part Approval Process or product warrant submission
Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities
Promote the use of preferred techniques for continuous improvement such as Lean, Poka-Yoke, Measurement System Analysis, and Process Failure Mode and Effects Analysis (PFMEA)
Provide leadership to identification and development of suppliers with respect to technology, performance, quality, cost, logistics, and delivery through the application of professionally accepted techniques, practices and procedures

Qualification

Supplier AuditQuality SystemsLean PrinciplesStatistical Process ControlLead Auditor CertificationMedical Device IndustryMinitabInnovative & CreativeCommunication SkillsProblem SolvingOrganizational SkillsInterpersonal Skills

Required

Bachelor's Degree in Engineering (Electrical, Mechanical) and 5 years of related experience in a manufacturing environment
Proficient in the above competencies and or an equivalent combination of education and experience
Strong organizational, interpersonal, analytical, communication and presentation skills
Requires daily onsite presence

Preferred

Electrical Engineering degree preferred
Lead Auditor Certification ISO 9001 and 13485 preferred
Lean Green belt preferred
Medical Device Industry experience preferred
Experience with Mini-tab application plus
Experience working with suppliers of PCBAs and other electrical components is highly preferred

Benefits

Most locations offer a 9/80 schedule, providing every other Friday off
Competitive compensation & 401(k) program to plan for your future
Robust medical, dental, vision, & disability coverage with qualified wellness discounts
Basic Life Insurance and Additional Life & AD&D Insurances are available
Flexible Vacation & PTO
Paid Parental Leave
Generous Employee Referral Program
Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
Voluntary Tricare Supplement available for military retirees

Company

HiArc

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At HiArc we believe clients don’t need another vendor, they need a strategic partner who gets it.

H1B Sponsorship

HiArc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase