Responsible for Supplier Quality Assurance of new product designs and product line extensions led by Research and Development at the surgical business unit including, but not limited to: product sourcing decision support; advanced product quality planning; suppliers assessment and qualification; validation of supplier processes; qualification of parts and/or finished products; and concern resolution process leadership.
Additionally, it may function in the same capacity to support maintenance of business (MOB) projects and cost improvement (CIP) projects.
Represent Supplier Quality in internal project meetings and manufacturing readiness reviews, and leads supplier on multiple Quality deliverables during qualification phases.
Acts as the Supplier Quality liaison between Manufacturing, R&D Engineering, Purchasing, Operations Quality, and the supplier.
Supports purchasing and R&D with source identification, evaluation and selection. Leads On-Site Assessments and supplier questionnaires of potential suppliers.
Assists R&D and the project team in the definition of critical product characteristics, and provides feedback on design manufacturability assessments to ensure a successful design transfer with robust specifications to suppliers.
Coordinates supplier activities necessary to fulfill B+L general and specific requirements for product qualification such as First Article Inspection, receiving inspection processes, supplier process controls, capability studies for critical product characteristics and implementation of PFMEAs and Control Plans, process validation, among others.
Develop and maintain local supplier management procedures to ensure that regulatory, local and corporate requirements are met. Review and provide input to new/revised corporate procedures that impact the site.
Perform supplier audits for new suppliers to assure products/services meet the requirements of applicable ISO standards, regulations, product specifications and B+L local and corporate requirements.
Responsibilities may include up to 15% travel.
Reviews receiving inspection results and verify first receipt is accepted.
Reviews and approves supplier-related Change Notices and documentation for new products and/or services.
Ensures resolution of supplier related quality problems, including internal failures, customer complaints and audit findings by managing nonconforming product disposition, supplier investigation of root cause, corrective action planning, implementation, and verification of effectiveness.
Establishes, reports, and sustains key supplier quality performance metrics and corresponding training, improvements and reporting responsibilities.
Ensure supplier documentation is maintained including risk assessments, quality agreements, and quality system certifications.
Supports costs of quality reduction goals and supplier risk mitigation activities.
Authoring, reviewing and implementation of policies and procedures, to drive supplier quality improvement processes for continuous improvement.
The scope of the position is primarily focused on suppliers for new products with extended scope to support supplier quality issues affecting current operations.
BS in Business, Biology, Chemistry, Engineering or Pharmacy (or equivalent experience)
Preference given to degreed engineers or technical degree type.
Excellent verbal and written communication skills. Ability to prioritize multiple tasks and projects with limited direct supervision. Effective organization and negotiation skills. Strong ability to manage suppliers, follow-up and complete projects. Proficient in MS Office Applications
Required - Demonstrated hands on supplier management experience at FDA and ISO Regulated environment.
5+ years’ Quality experience in the Medical Device Manufacturing industry; 3+ years in supplier quality related processes. Must have proven and results-driven track record of successfully managing projects, people and suppliers. Responsible for developing & implementing quality processes in a global business environment, including supplier manufacturing sites.
Additional consideration for experience in other highly regulated industries (automotive, aerospace, etc.) and for the following certifications: ASQ CQE, CQA, CQM and Six Sigma Green Belts, Black Belts, and Master Black Belts.