Senior Global Supplier Quality Professional

Kindeva Drug Delivery

. Execute global supplier quality strategies, policies, and procedures across regions and business units.

Posted 9/23/2026full-timeRemote • Minnesota • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Supplier Quality Management, ensuring compliance with regulatory standards such as ISO 13485 and FDA requirements. Proficient in leading supplier audits, driving continuous improvement initiatives, and utilizing quality tools like FMEA and SPC to enhance product quality.

Highest-signal resume keywords

Supplier Quality ManagementQuality Management Systems (QMS)Regulatory Standards ComplianceSupplier Audits and CAPA ManagementAdvanced Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier Quality ManagementQuality Management Systems (QMS)Regulatory Standards ComplianceSupplier AuditsCAPA ManagementFMEAStatistical Process Control (SPC)Process ValidationRoot Cause AnalysisChange Control

Soft Skills

Excellent CommunicationStakeholder ManagementProject ManagementInfluencing Without AuthorityAnalytical Capability

Certifications & Qualifications

ASQ Certification (CQE, CQA, CSQP)Six Sigma Green/Black Belt

Industry Keywords

Medical DevicePharmaceuticalRegulated IndustryNew Product Introduction (NPI)Supplier Validation

About the role

Key responsibilities & impact

Execute global supplier quality strategies, policies, and procedures across regions and business units.
Ensure supplier quality processes align with QMS requirements and regulatory standards.
Partner with Global Supply Chain and Procurement on supplier segmentation, risk classification, and oversight models.
Assist with supplier selection, qualification, onboarding, and inclusion 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.
Execute supplier development programs to improve process capability, reduce variability, and enhance product quality.
Represent Global Supplier Quality in root cause investigations and resolve supplier quality issues using structured methodologies such as 8D and DMAIC.
Drive Supplier Corrective and Preventive Actions (SCAR/CAPA) and verify effectiveness.
Execute non-conformance, deviation, and escalation processes across the global supply base.
Ensure supplier controls meet applicable ISO 13485, FDA, and GMP requirements.
Support internal and external audits, inspections, and regulatory submissions related to supplier quality.
Maintain audit readiness through 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.
Work cross-functionally with internal stakeholders and global suppliers.
Mentor junior supplier quality professionals and provide technical guidance.
Assist in cross-functional and cross-regional initiatives to drive harmonization and best practices.
Influence decision-making through data-driven insights and supplier performance analytics.

Requirements

What you’ll need

Bachelor’s degree in life sciences, engineering, or related field required; advanced degree preferred.
8+ years of progressive quality experience in Supplier Quality, Quality Engineering, or Quality Systems in a regulated industry.
Demonstrated experience working with global suppliers and cross-regional teams.
Strong knowledge of Quality Management Systems (QMS) and supplier controls.
Experience with regulatory standards such as ISO 13485, ISO 9001, FDA 21 CFR Part 820, and/or GMP requirements.
Proficiency in quality tools and methodologies (e.g., FMEA, SPC, process validation, statistical analysis).
Experience managing supplier audits, CAPA systems, and change control processes.
Advanced problem-solving and root cause analysis capabilities.
Strong project management skills with ability to manage multiple initiatives globally.
Excellent communication and stakeholder management skills across technical and non-technical audiences.
Ability to influence without authority and drive accountability across a global supply base.
High level of analytical capability with experience interpreting supplier performance data.
Willingness to travel globally up to 30%.
ASQ Certification (CQE, CQA, CSQP) or equivalent preferred.
Six Sigma Green/Black Belt preferred.
Experience in medical device, pharmaceutical, or other highly regulated industries preferred.
Experience supporting new product introduction (NPI) and supplier validation activities preferred.