Supplier Component Quality Engineer Jobs

Interface between internal departments and on site supplier development and management.

Foster and maintain strong relationships with key suppliers as an extension of the primary points of contact.

Perform on-site audits and evaluations to ensure suppliers meet the company's quality and performance standards.

Implement continuous improvement initiatives to enhance the overall quality of supplied components.

Collaborate on design for manufacturability (DFM) initiatives to enhance component manufacturability and assembly.

Proactively identify potential issues or bottlenecks in the supply chain and manufacturing processes.

Experience in project management, manufacturing floor, fast-paced medical device operations environment and component supplier manufacturing process.

Demonstrated understanding of QSR and ISO standard (ISO 9001, ISO 13485) requirements for Material/Purchasing Controls, Validation and CAPA.

Experience with materials/components specifications and manufacturing processes.

Experience with Laboratory Equipment: Measuring Tools and Failure Analysis.

Experience with inspection methods for components i.e., analytical, or dimensional test methods.

Experience with problem solving quality tools.

Excellent Project Management skills that drive transparency, accountability, and results.

Proven business/technical writing, presentation, planning, problem solving, organizational, project management and judgement skills.

Working knowledge of Quality Management Systems/Specifications (i.e., AS9100, Nadcap, ISO 9001, etc.…).

Perform other job-related duties as assigned by Quality Management.

Working knowledge of major aerospace prime customer (i.e., Boeing, AIRBUS, etc.…) requirements is a plus.

Manage Supplier Corrective Action Requests.

Experience in process validation, design controls, risk management, and CAPA.

Experience with quality systems and processes, and project management.

Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.

BS degree in engineering or related technical field with minimum of 3-5 years of relevant experience.

Experience with medical device suppliers

Experience as lead auditor of quality systems (ISO13485 or similar)

CQA, MDSAP Lead Auditor Certification or demonstrated compliance auditing experience.

iota offers a very competitive benefits package that includes the following:

Drive quality improvement projects to include compliance to new or updated requirements or guidance

5 Minimum years of relevant experience.

5 Years Class III Medical Device experience.

Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail

Supplier quality management experience and a deep understanding of problem-solving tools including 8D principle and statistical process control principles

In-depth knowledge of memory quality and reliability concept including qualification report and JEDEC reliability standard

MS/BS in engineering or equivalent experience

7+ years of significant experience in memory quality

Knowledge of DRAM, eMMC, SSD operation and understanding key AC/DC parameters in datasheet

Experience with semiconductor factory audits and data analysis using Excel, Mintab, or JMP

5-8 years' experience hands-on experience with the ISO9100 and AS9100 Quality Management Systems Processes, especially in Production, Quality, and logistics

Knowledge of, (or hands-on experience preferred), with FAA, EAR, and ITAR standards and regulations

Project management, time management, problem solving and organization

Bachelor's degree from an accredited college in a technical discipline, (i.e., Industrial Engineering, Mechanical Engineering, Quality Management, etc.)

8+ years of hands-on experience as a Quality Engineer in an Aerospace Manufacturing Environment

5-8 years of FAI experience with AS9102 (FAI) standards at a quality engineering level.

Interface with Project Management, Operational Excellence, and Digital Solutions to support part qualification approvals.

Streamlining qualification of components and assemblies from Suppliers to Customers, involving:

Creating/modifying the current excel workbooks to create a mistake proof template and ensure clear and uniform communication of requirements.

Create guidance material on the completion of First Article Submissions, PPAPs, and Process Qualifications.

Develop a method of tracking the status of qualification packages.

Support preparation of First Article Submissions, PPAPs, and Process Qualifications, testing the above method.

Experience in IATF16949 type requirements, APQP, PPAP, DFMEA, PFMEA required.

Facilitate communication, clarification of technical requirements, and Design for Manufacturing (DFM) between Suppliers and Purchasing, Quality, and Design teams.

Conduct supplier audits to ensure their capabilities to meet part performance, delivery, and reliability expectations during supplier selection.

5+ years of experience developing and launching complex assembly processes.

Experience with Geometric Dimensioning & Tolerancing (GD&T) and a broad variety of measurement and inspection techniques.

Automotive or agricultural manufacturing experience is a plus.

Strong experience working across an organization using written and verbal skills to communicate and understand cross functional teams, interactions and responsibilities

Support Released Product Management (RPM) projects to ensure that suppliers deliver quality parts, materials, and services

Root cause investigation and Supplier CAPA management

Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods

Bachelor's Degree and 4+ years of Supplier Quality Engineering experience OR advanced degree and 2+ years of experience

ASQ CSQP and/or CQE certification

Primary POC for; Internal review meetings, Project Management Reviews, and liaison with Suppliers QA teams supporting current and future contracts

Use quality improvement tools such as 8D, Six-Sigma, Kaizen and metric management and reporting.

Work with Supply Chain, Quality Control, Engineering, and Program Management to ensure incoming material meets product specifications.

Experience in interpreting contract conditions covering quality requirements and quality planning

Support program, product development, and engineering groups covering key QA requirements.

Represent QA team with internal and external customers regarding QA requirements and outputs in formal and informal settings.

BS degree in Mechanical or Electrical Engineering with 0 - 2 years related experience.

Experience with quality systems, quality processes, internal auditing, or ISO13485

Experience with manufacturing support or process development

Experience with medical device suppliers

Monitors supplier performance to drive improvement and corrective action in the quality of components sourced from outside suppliers.

Develops and maintains incoming acceptance methods for materials and trains incoming inspectors to procedures.

Hybrid role (3 days onsite and 2 days remote).

Supplier quality engineering will be a plus as major responsibilities lean in that direction.

Working on new product development.

Creating components for next-generation devices.

They will get components from R&D engineers and some of the deliverables for this engineer will be supplier selection and evaluation.

Evaluate current suppliers and new suppliers.