Senior Supplier Quality Engineer

Jobtailor; Arizona; On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a supplier quality professional to lead supplier transfers and drive QA initiatives for medical devices in a regulated environment. You will validate processes, support design transfer to manufacturing, and coordinate quality metrics with business teams to enable data-driven decisions.

The ideal candidate has experience with Windchill and Agile PLM, PPAP, GD&T, and Six Sigma, plus strong cross-functional leadership and communication skills to influence suppliers and internal

Qualifications

• Bachelor’s degree in Engineering/Science with 4+ years in a regulated industry.
• Advanced degree in Engineering/Science with 2+ years in a regulated field.
• PhD with 0 years of relevant experience.

Responsibilities

• Management of supplier transfers within the Global Supplier Quality Supplier Change Implementation Team.
• Provide QA Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements.
• Coordinate feedback of quality indicators and statistics to business team for use in business decisions.
• Perform, direct, or consult in supplier validations.
• QA approvals for Engineering Change Notices, test methods, and test equipment.

Skills

Supplier Controls Management

Change Management

Root Cause Analysis

Project Leadership

Communication Skills

Problem-Solving Skills

Process Improvement

Education

Bachelor's Degree in Engineering/Science

Advanced Degree in Engineering/Science

PhD

Tools

Windchill

Agile PLM

Minitab

Job description

• Management of supplier transfers within the Global Supplier Quality Supplier Change Implementation Team.
• Provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements.
• Coordinate feedback of quality indicators and statistics to business team for use in business decisions.
• Perform, direct, or consult in supplier validations.
• QA approvals for Engineering Change Notices, test methods, and test equipment.

Requirements

• Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in a regulated industry OR PhD with 0 years relevant experience.
• Strong knowledge of Supplier Controls, including creation and maintenance of supplier files in the Approved Supplier List (ASL).
• Experience with Windchill and Agile PLM systems.
• Working knowledge of FDA regulations and ISO standards for implantable and non-implantable medical devices.
• ASQ certification preferred, such as CQE, CQA, and/or CSQP.
• First Time Quality Coach (FTQ) Six Sigma, DFSS, or Lean Green Belt/Black Belt certified.
• Knowledge of PPAP, part/product validation, and qualification processes.
• Strong technical knowledge of metrology, measurement techniques, GD&T, measurement uncertainty, Gauge R&R, and statistical analysis using tools such as Minitab.
• Demonstrated ability to influence and negotiate with suppliers and lead successful change initiatives.
• Strong project leadership skills, including balancing risk and benefit, influencing cross-functional teams, and driving accountability for outcomes.
• Excellent communication, organizational, presentation, judgment, and problem-solving skills, with the ability to operate strategically and tactically (especially root cause analysis).

Core Competencies

Demonstrates expertise in Supplier Quality Management, including Supplier Controls and validation processes, while effectively leading cross-functional teams and influencing supplier relationships. Proficient in regulatory compliance with FDA regulations and ISO standards, alongside strong analytical skills in metrology and statistical analysis.

Highest-signal resume keywords

• Supplier Controls Management
• FDA Regulations Knowledge
• ISO Standards Compliance
• Six Sigma Certification
• Project Leadership Skills

ATS Optimization Keywords

Hard Skills

• Supplier Validation
• Metrology
• Statistical Analysis
• GD&T
• Measurement Techniques
• Part/Product Validation
• Quality Assurance Engineering
• Change Management
• Root Cause Analysis
• Process Improvement

Soft Skills

• Communication Skills
• Organizational Skills
• Problem-Solving Skills
• Negotiation Skills
• Presentation Skills

Certifications & Qualifications

• ASQ Certification
• CQE
• CQA
• CSQP
• Six Sigma Green Belt
• Six Sigma Black Belt

Industry Keywords

• Regulated Industry
• Medical Devices
• Approved Supplier List
• First Time Quality Coach
• PPAP

Tools & Technologies

• Windchill
• Agile PLM
• Minitab