This position has the responsibility for leading the Spine Supplier Quality program and executing associated systems, processes, programs/initiatives, practices, and metrics for ensuring and improving overall Supplier Quality performance. This position is based in Westminster CO. The position partners with other Zimmer Biomet Supplier Quality leaders as well as representatives from Sourcing, Development, Research and other functions to lead and collaborate on Supplier Quality Management improvements. Develops and manages the department to assess and ensure compliance to the FDA Quality System Regulations, ISO 13485 Quality System Standard, UR MDR, JPAL and other applicable regulations. Manages the Westminster Supplier Audit Program and maintains supplier audit reports, supplier qualification documentation and supplier certifications. The candidate may be assigned additional quality and regulatory compliance related duties as required by the VP of Quality.
Principal Duties and Responsibilities
- Leads and aligns Supplier Quality strategy and execution to Site goals and objectives (eg, Reduction of Dependency on Inspection, Reduce Supplier Base), and drives compliance to Supplier Quality systems and expectations. Leverages resources and processes to drive change and improves Supplier Quality performance
- Partners with cross functional department leaders and works closely with Operations, Sourcing, Research and Development to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, assessing new and existing suppliers, performing supplier audits, and other documented requirements for quality objectives. Participates in new product development to select suppliers, qualify new suppliers, and setup supplier controls. And responsible for sustaining quality activities.
- Leads, develops, modifies and implements Supplier Quality procedures, systems, processes and metrics to drive standardization and common practices across the sector. Works with local site Quality leaders to ensure Supplier Quality requirements, goals and objectives are met at both site and sector levels. Provides support in investigations and reports on supplier corrective actions effectiveness and timeliness including complaint investigations, NCRs, SCARs and supplier related CAPAs. Reports on key site wide and specific supplier quality metrics.
- Represents Supplier Quality performance internally and externally including during the interactions with regulatory agencies, customers, suppliers and others. Participates in supplier audits to drive improvements. Participates in regulatory inspections and audits to represent Supplier Quality to achieve no major issues and demonstrates full compliance. Participates on Corporate Supplier Quality initiatives as requested.
Understands the regulatory requirements both domestic and international and ensures the regulatory requirements are met. Demonstrates knowledge of FDA QSR, ISO 13485, EU MDR, CMDR/CMDCAS, JPAL and other regulations. Complies with the site Quality Policy and Quality Management System.
Expected Areas of Competence
- Supplier Quality Management/Leadership Experience.
- Excellent Interpersonal and Communication skills
- Knowledge of quality system requirements.
- Formal training and experience in auditing preferred.
- Demonstrated skill in root cause analysis and corrective action implementation.
- Understanding of QSR in the medical device industry
- Excellent oral, writing, and presentation skills
- Excellent analytical and problem solving skills
- Basic computer skills including Microsoft applications, and database management.
- Engineering background including expertise in production environment in the medical device field preferred
- Ability to deliver innovative, cost-effective and timely solutions in a multiple project environment.
- Understanding of continuous improvement methodologies including lean, six sigma, and validation
- B.S. in Engineering or technical discipline with at least 6-8 years of experience including relevant supplier quality and leadership experience.
- CQE and CQA certification preferred.