Principal Engineer, Supplier Quality
- Job Number: 20147581
- Country: Costa Rica
- Date Posted: 9/4/2024
- Type: Full time
- Employment Type: Regular
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.