Senior Global Supplier Quality Professional

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Implement global supplier quality strategies, policies, and procedures across various regions and business units.

• Ensure that supplier quality processes are in compliance with QMS requirements and regulatory standards.

• Collaborate with Global Supply Chain and Procurement on supplier segmentation, risk classification, and oversight models.

• Assist in the selection, qualification, onboarding, and inclusion of suppliers in Approved Supplier Lists.

• Conduct and/or lead supplier audits, including initial, surveillance, and for-cause audits.

• Maintain supplier quality agreements, specifications, and performance expectations.

• Monitor supplier performance metrics such as defect rates, on-time delivery, and cost of poor quality.

• Identify performance trends and drive continuous improvement initiatives with suppliers.

• Implement supplier development programs to enhance process capability, reduce variability, and improve product quality.

• Represent Global Supplier Quality in root cause investigations and address supplier quality issues using structured methodologies such as 8D and DMAIC.

• Drive Supplier Corrective and Preventive Actions (SCAR/CAPA) and verify their effectiveness.

• Manage non-conformance, deviation, and escalation processes across the global supply base.

• Ensure supplier controls comply with relevant ISO 13485, FDA, and GMP requirements.

• Support internal and external audits, inspections, and regulatory submissions related to supplier quality.

• Maintain audit readiness through effective documentation, traceability, and quality records.

• Partner with R&D, Engineering, and Operations on new product development and supplier integration.

• Provide supplier quality input into design controls, risk management, and validation activities.

• Collaborate cross-functionally with internal stakeholders and global suppliers.

• Mentor junior supplier quality professionals and offer technical guidance.

• Assist in cross-functional and cross-regional initiatives to promote harmonization and best practices.

• Influence decision-making through data-driven insights and supplier performance analytics.

⛳️ Requirements

• Bachelor’s degree in life sciences, engineering, or a related field is required; an advanced degree is preferred.

• A minimum of 8 years of progressive quality experience in Supplier Quality, Quality Engineering, or Quality Systems within a regulated industry.

• Proven experience working with global suppliers and cross-regional teams.

• Strong understanding of Quality Management Systems (QMS) and supplier controls.

• Familiarity with regulatory standards such as ISO 13485, ISO 9001, FDA 21 CFR Part 820, and/or GMP requirements.

• Proficient in quality tools and methodologies (e.g., FMEA, SPC, process validation, statistical analysis).

• Experience in managing supplier audits, CAPA systems, and change control processes.

• Advanced problem-solving and root cause analysis skills.

• Strong project management abilities with the capacity to oversee multiple global initiatives.

• Excellent communication and stakeholder management skills for both technical and non-technical audiences.

• Ability to influence without authority and foster accountability across a global supply base.

• High level of analytical ability with experience in interpreting supplier performance data.

• Willingness to travel globally up to 30% of the time.

• ASQ Certification (CQE, CQA, CSQP) or an equivalent is preferred.

• Six Sigma Green/Black Belt is preferred.

• Experience in medical device, pharmaceutical, or other highly regulated industries is preferred.

• Experience supporting new product introduction (NPI) and supplier validation activities is preferred.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Competitive salary and performance-based incentives.

• Flexible work arrangements.

• Collaborative and inclusive work environment.