Principal Engineer, Supplier Quality (首席供应商质量工程师)

What Supplier Quality contributes to Cardinal Health

Quality 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.
 

The Principal Engineer, Supplier Quality entails the following :

Responsibilities

• Adhere to Good Manufacturing Principles (GMPs) based Quality Management Systems requirements for medical devices and medicinal products

• Identify and lead implementation of preventive and corrective actions via CAPAs, audits, NCMRs, and complaint handling systems

• Lead implementation of Supplier Change Requests and utilize Production Part Approval Process (PPAP)

• Key contributor on NPD (New Product Development) projects, ensuring rigorous performance and APQP deliverables (CTQ, PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA, etc.), in collaboration with Procurement, Manufacturing and R&D

• Ensure supplier quality systems adhere to all applicable regulations and standards

• Ability to lead and influence cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance

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

• Drive new process, system implementation within supplier quality lifecycle team

• Identify and lead continuous process/products improvement/excellence initiatives/projects

• Ensure supplier quality systems adhere to all applicable regulations and standards

Qualifications

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

• 8 + years experience as minimum, of which preferably  >5  years in manufacturing quality/Engineering quality/supplier quality in medical device industry

• 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.

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

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

• 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

• Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans

• 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.

• > 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.