About the Role

We are seeking a dedicated Manager, Supplier Quality Assurance to join our team in a remote capacity. In this role, you will provide leadership and direction to the Supplier Quality Engineering staff, ensuring compliance with regulations and standards while enhancing quality systems and processes.

What You'll Do

  • Lead and mentor the Supplier Quality Engineering team, fostering a culture of continuous improvement.
  • Oversee supplier qualifications, audits, and corrective actions to maintain high-quality standards.
  • Collaborate with cross-functional teams to drive quality initiatives and optimize supplier performance.
  • Analyze data to monitor supplier performance and develop KPIs for ongoing assessment.
  • Ensure compliance with relevant regulations, including ISO 13485 and QMSR, during supplier evaluations.

Requirements

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline; advanced degree preferred.
  • 10+ years of experience in supplier quality assurance within the medical device industry, including 3+ years in a managerial role.
  • Strong understanding of supplier management processes, including audits and quality agreements.
  • Excellent communication and interpersonal skills for effective collaboration with suppliers and internal teams.
  • Certified Auditor Qualification or equivalent is required.

Nice to Have

  • Experience with Production Part Approval Process (PPAP) and Process Validation.
  • Proficiency in Measurement System Analysis (MSA).
  • Knowledge of risk management principles in supplier quality.

What We Offer

  • Competitive salary range of $145,000 to $166,000 per year.
  • Remote work flexibility, allowing you to work from anywhere.
  • Opportunities for professional development and continuous learning.
  • Collaborative work environment with a focus on quality and innovation.
  • Travel opportunities of approximately 25%-40% for supplier audits and evaluations.
Why This Job8.5 of 10

This remote Manager, Supplier Quality Assurance position offers a competitive salary and the opportunity to lead quality initiatives in a dynamic environment.

Salary Range
Required
0/1
Optional
0/1
Bonus
0/1

Who Will Succeed Here

In-depth knowledge of ISO 13485 standards and Quality Management Systems, with practical experience conducting Supplier Audits and ensuring compliance in a technology-driven environment.

Strong analytical mindset and problem-solving skills, essential for troubleshooting and optimizing Supplier Quality Assurance processes in a fully remote work setting.

Proven leadership abilities in mentoring teams, fostering a culture of continuous improvement and collaboration, particularly in remote teams, to enhance quality systems and processes.

Learning Resources

ISO 13485:2016 - Quality Management Systemsguide

Career Path

Manager, Supplier Quality Assurance(Now)Director of Quality Assurance(2-4 years)Vice President of Quality and Compliance(5-7 years)

Market Overview

Market Size 2024
$12B
Annual Growth
8.5%
AI Adoption in Quality Assurance
35%
Investment in Quality Management Systems
+25%
Labour Demand for Quality Assurance Roles
+15%
Avg Salary for Supplier Quality Managers
$110K

Skills & Requirements

Required
Supplier Quality AssuranceISO 13485Quality Management Systems
Growing in Demand
Data Analytics for Quality ControlRisk Management in Supply ChainsLean Six Sigma Methodologies
Declining
Manual Inspection TechniquesBasic Statistical Process Control (SPC)

Domain Trends

Increased Automation in Quality Assurance
Over 40% of organizations are adopting automation tools for quality assurance processes to enhance efficiency and reduce human error.
Shift Towards Integrated Quality Management Systems
Around 30% of companies are transitioning to integrated systems that combine quality management with supply chain management, enhancing real-time monitoring.
Growing Importance of Regulatory Compliance
With 50% of companies facing stricter regulations, there is a heightened focus on compliance and quality assurance processes, increasing demand for skilled professionals.

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