Associate Director, Device Supplier Management

Position Overview Associate Director, Quality System & Compliance – responsible for leading QMS Purchasing Controls and Device Supplier Management initiatives across MDCP programs, ensuring compliance with cGMPs, global regulations, and continuous improvement. Primary Responsibilities Lead early commercialization Purchasing Controls processes and integrate Supplier Management activities across MDCP lifecycle. Conduct supplier qualification, evaluation, audits, and performance monitoring; maintain supplier quality agreements. Drive continuous improvement initiatives and address quality and regulatory issues. Support investigations of supplier-caused deviations, CAPAs, and preventive actions. Develop and implement phase-appropriate supplier controls for development and early commercialization stages. Collaborate with Procurement and MDCP sites to support new or revised QMS Quality Standards and global procedures. Enter supplier, product, and audit data into electronic systems such as SAP, Veeva Vault, and supplier management platforms. Manage related activities within the QMS and coordinate cross-functional teams. Qualifications B.S. or M.S. in an appropriate scientific or engineering discipline. Minimum 8 years experience in pharmaceutical, medical device, or combination product environments, including 4 years in Supplier Quality Management or Purchasing Controls. In-depth knowledge of FDA 21 CFR Part 4 & 820, EU MDR 2017/745, ISO 13485:2016, and related regulatory requirements. Demonstrated experience in supplier audit planning, execution, and follow-up. Strong understanding of device design, manufacturing, packaging, testing, release, storage, and distribution. Proficiency with QMS documentation, document control, and quality system maintenance. Excellent communication, organizational, and cross-functional collaboration skills. Preferred Skills Adaptability, strategic planning, risk management, GMP compliance, design controls, and employee training. Experience with vendor performance monitoring and supplier relationship management. Compensation & Benefits Salary range: $129,000.00 – $203,100.00. Eligible for annual bonus and long-term incentive, if applicable. Comprehensive benefits include medical, dental, vision, retirement, paid holidays, vacation, and compassionate/sick days. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement #J-18808-Ljbffr MSD Malaysia