Principal Supplier Quality Engineer - Tijuana, México - Cardinal Health

Cardinal Health

Empresa verificada

Tijuana, México

hace 2 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

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.

Responsibilities

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 crossfunctional teams
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 crossfunctional teams, including Procurement, Regulatory Affairs, Technical Services and Research & Development to drive reduction in patient safety risk and greater levels of regulatory compliance
Travel: 10%15%

Qualifications

Bachelor's degree in Engineering, Quality or closely related field
5+ years Supplier Quality or related experience
Advance/Fluent proficiency in English and Spanish
Experience working with suppliers in one of the following industries: Engineering materials plastics, metals and metal alloys, ceramics, composites
Extensive Medical device manufacturing processes knowledge including extrusion and/or molding
Experience with Validation (Installation Qualification (IQ), Optimization Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV))
Strong organizational and communication skills
Knowledge of Lean, and 6 Sigma principles preferred
Knowledge of Risk Management (DFMEA, PFMEA) preferred
Working knowledge of business platforms and processes SAP, BPCS and Agile PLM 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
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._