Principal Engineer, Supplier Quality

What does Supplier Quality bring 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.

• Drive the creation of a robust supplier quality lifecycle management strategy for assigned commodity or product segment beginning with initial supplier selection through retirement

• Establish a process to technically assess the capabilities of suppliers in a commodity or product segment

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

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

• Manage applicable internal corrective actions to assure effectiveness and avoid repeat issues

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

Responsibilities

• 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

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

• 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

• 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)

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

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

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

• The ability to take responsibility for the professional development of self

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

• Travel: 10%-15%

Qualifications

• Bachelor’s degree in engineering, preferred or equivalent work experience

• 5 - 8 years of related experience preferred

• Extensive Medical device manufacturing processes knowledge including wound care products, foams, dressings, prep pads, wovens, non-wovens, automation, assembly, sterilization and validation preferred

• Knowledge of Lean, and 6 Sigma principles preferred

• Knowledge of Risk Management (DFMEA, PFMEA) preferred

• Experience with Validation (Installation Qualification (IQ), Optimization Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV)), preferred

• Working knowledge of business platforms and processes SAP, BPCS and Agile PLM preferred

• Strong organizational and communication skills

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.