Manager, Supplier Quality (供应商质量经理)

What Supplier Quality contributes to Cardinal HealthQuality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues.

Manager, Supplier Quality Management entails the following

Responsibilities  

• Dedication toward ensuring patient safety, regulatory compliance and ongoing business success

• Drive the creation & effective execution of a robust supplier quality lifecycle management strategy for assigned commodities or product categories beginning with initial supplier/product qualification through retirement

• Drive execution and improvement of external supplier/product qualification process for assigned commodity or product categories

• Guide team members and supplier to greater levels of knowledge and application in Quality Management incl. Change Management, Corrective and Preventive Action (CAPA), Process Validation and Production/Process Controls, etc.

• Collaborate with peers, stakeholders, and team members to improve external supplier /product qualification procedures and documents to improve supplier oversight

• Identify and lead assigned continuous improvement projects for either suppliers or internal cross-functional teams

• Adhere to applicable regulations, standards and CAH quality management system requirement for medical devices and medicinal products

• Drive for corrective/preventive and continuous improvement activities to assure CAH supplier quality process effectiveness and avoid repeat issues

Accountabilities:

• Ability to lead and influence cross-functional teams, including Procurement, Regulatory Affairs, Technical Services and Research & Development to drive reduction in patient safety risk and greater levels of regulatory compliance

• Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance

• • Excellent written and verbal communication skills to drive clear alignment of company and department goals

Qualifications

• Bachelor degree in Science or Engineering, advance degree preferred.

• At least 8-12 years experience in related fields, of which preferably 5 + years in manufacturing quality/Engineering quality/supplier quality in heathcare industry e.g. medical device

• Apply experience and knowledge of ISO 13485 (Quality Management Systems), FDA medical device regulations, cGMP, and Risk Management (ISO 14971) to instil a culture dedicated to ensuring patient safety and sustained regulatory compliance

• Solid experience/knowledge of quality process management and tools e.g. APQP, PPAP, SPC, Statistics Tools and Analysis in development and revision of Quality Sampling Plans based on product and patient risk.

• Ability to lead and influence cross-functional teams, including Procurement, Regulatory Affairs, Engineering and Research & Development to drive reduction in patient safety risk and greater levels of regulatory & quality compliance

• Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance

• Excellent written and verbal communication skills to drive clear alignment of company and department goals

• Commitment to work within the ethos of the company mission, code of conduct and applicable legal standards/regulations

• Proficient English, working language for reading, writing and oral communication.

• Minimum 10 - 20% travel expected

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.