Senior/Principal Engineer, Supplier Quality (高级/首席工程师, 供应商质量管理)

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.
 

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 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

Qualifications

• 4-8 years of experience, preferred

• Bachelor's degree in related field, or equivalent work experience, preferred

What is expected of you and others at this level

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects

• May contribute to the development of policies and procedures

• Works on complex projects of large scope

• Develops technical solutions to a wide range of difficult problems

• Solutions are innovative and consistent with organization objectives

• Completes work; independently receives general guidance on new projects

• Work reviewed for purpose of meeting objectives

• May act as a mentor to less experienced colleagues

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.