Supplier Quality Specialist

Position Overview

Our client, a leading medical device company, is seeking a Supplier Quality Analyst to support a large-scale Quality Agreement remediation initiative involving approximately 250 supplier agreements. The consultant will help drive a high volume of Quality Agreement amendments to completion by communicating requirements to external suppliers, addressing routine questions and objections, negotiating within established guidelines, documenting outcomes, and escalating more complex issues to leadership as needed.

This is a highly execution-focused role. The ideal candidate will be organized, proactive, and comfortable managing a large portfolio of agreements while communicating professionally with external supplier contacts. A strong understanding of regulated quality environments is important, but the individual does not need to be a Supplier Quality subject matter expert.

Key Responsibilities

• Manage and drive a portfolio of Quality Agreement amendments through completion.
• Conduct outreach to external suppliers and communicate required amendment terms and Quality System requirements.
• Explain the rationale behind requested changes, including regulatory and record-retention requirements.
• Address routine supplier questions, concerns, and objections and conduct first-pass negotiations within established guidelines.
• Review supplier redlines and recommend appropriate responses or escalate issues requiring Quality, Legal, or leadership review.
• Collaborate with Supplier Quality, Sourcing, Legal, and other internal stakeholders to resolve issues and maintain momentum.
• Maintain accurate documentation of supplier communications, negotiations, decisions, and amendment status.
• Track progress, identify stalled agreements, and proactively follow up with suppliers and internal stakeholders.
• Escalate complex or high-risk issues appropriately while independently managing routine matters.
• Support project reporting, metrics, and leadership visibility into remediation progress.
• Help maintain a consistent and efficient process for moving a high volume of amendments toward closure.

Ideal Background

The ideal candidate will have 2–4 years of experience in a regulated medical device or life sciences environment, with exposure to one or more of the following:

• Supplier Quality
• Supplier Management
• Quality Agreements
• Contract or agreement administration within a regulated environment
• Regulatory or Quality documentation remediation
• Experience working directly with external suppliers and negotiating or resolving contract or documentation issues is highly desirable.

Required Skills

• Bachelor's degree in a relevant field or equivalent education/experience
• 2–4 years of experience in a regulated medical device or life sciences environment
• Strong written and verbal communication skills
• Comfortable communicating directly with external suppliers
• Strong negotiation and relationship-management skills
• Ability to understand and communicate the rationale behind Quality System and regulatory requirements
• Working knowledge of regulated quality environments and medical device terminology
• Strong attention to detail and documentation skills
• Excellent organizational and project-management abilities
• Ability to manage a high volume of work while maintaining accuracy and follow-through
• Strong problem-solving and critical-thinking skills
• Proficiency with Microsoft Office Suite, particularly Excel, Word, and Outlook
• Prior experience with Quality Agreements or supplier quality documentation

Preferred Experience

• Familiarity with record-retention requirements in a regulated environment
• Experience reviewing contracts, amendments, or supplier redlines
• Experience working with Supplier Quality, Procurement/Sourcing, Legal, or cross-functional Quality teams
• Experience supporting remediation, compliance, audit-readiness, or quality-system improvement initiatives