Medical Device Senior Supplier Quality Engineer

Grove Technical Resources, Inc.; Brooklyn Center (MN); On-site; USD 73,000 - 99,000; Full time

Job summary

A leading company in the medical device industry is seeking a Senior Supplier Quality Engineer to ensure suppliers meet quality standards and deliver reliable products. The role involves audit planning, statistical analysis, and collaboration with new product development teams. Candidates should possess a relevant degree and significant experience in quality assurance.

Qualifications

• Bachelor's degree in relevant engineering field required.
• Minimum 4 years of experience in quality engineering or similar role.
• Experience with statistical analysis and quality control methods required.

Responsibilities

• Ensure suppliers deliver quality parts and materials.
• Monitor parts through their manufacturing cycle.
• Develop auditing schedules for supplier evaluation.

Skills

Quality Control

Statistical Analysis

Project Management

Gage R&R

Engineering Design

Education

Bachelor of Science in Mechanical Engineering, Chemical Engineering, Material Science

Job description

Medical Device Senior Supplier Quality Engineer

Medical Device Senior Supplier Quality Engineer

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Job Title: Medical Device Senior Supplier Quality Engineer

Type: W2 contract

Job Description:

Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Partner with Technical Sourcing to locate, evaluate, and approve new potential component/material suppliers that balance business, quality, and technical requirements.

Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow provide customers with the highest quality and reliable products.

Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified PPAP requirements.

Work to develop proper inspection tooling and test methods for new components to ensure supplier parts meet specification requirements. Perform statistical data analysis to determine tool and part/process performance. Evaluate Supplier capabilities for mechanical measurement via Gage R&R studies. Ensure appropriate acceptance activities are in place prior to commercialization.

Plan, execute, and communicate own work and educating others on work products. Provide regular, timely communication to manager and project team regarding status of assigned activities.

Metrology & Measurement; statistical analysis (Cpk, standard deviation, etc.), measurement uncertainty, GD&T, Gauge Repeatability & Reproducibility

Must Have: Minimum Requirements:

Bachelor of Science in Mechanical Engineering, Chemical Engineering, Material Science, or a similar discipline.

quality control/engineering

manufacturing/product / mechanical engineering

driving projects to closure / DMAIC / CAPA experience.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering, Education, and Manufacturing

• Industries

  Medical Practices, Medical Equipment Manufacturing, and Biotechnology Research

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