The Sr. Manager, Supplier Quality Management leads a global supplier quality team supporting the CooperSurgical organization. The individual is responsible for fulfilling the quality oversight and management of suppliers and service providers involved with the manufacture and service of finished goods, components, materials, custom materials, warehousing, and logistical services.
About the Role:
The position manages a team of supplier quality professionals and collaborates with cross functional organization partners including but not limited to the Global Quality team, Manufacturing and Supply Chain to ensure qualification and management of suppliers and service providers. This role establishes and maintains standard operating procedures in alignment with corporate quality standards, regulations and current GMP expectations. In collaboration with QA management, this position provides strategies, and solutions to achieve these responsibilities, improve the local quality system, and identify workstream efficiencies.
Responsibilities:
Provide direct leadership to the Global Supplier Quality team, including prioritization of workload and shifting of resources to support the needs of the business.
Develop vision and provide leadership for implementation of quality assurance responsibilities in the global management of direct, indirect, and purchased finished good suppliers (including supplier selection, evaluation, approval, re-evaluation, audit, and performance).
Tracking and reporting on supplier quality performance including but not limited to supplier complaints, corrective actions, and non-conformances.
Active participation at various corporate-wide and department-specific meetings and functions, including staff meetings, team meetings, technical and strategy meetings, representing Supplier Quality Assurance.
Collaborate with the manufacturing/supplier teams to ensure the achievement of existing quality levels of manufactured products and seek methods to continually improve quality and reduce customer complaints.
Provide input to the Global Quality Management strategic plan and budget.
Develop and maintain a plan for the professional development, coaching and performance management of all direct reports.
Advise and participate in IT solutions for quality system improvements for Global Supplier Quality.
Manage implementation of policies and procedures, to drive supplier quality improvement processes for continuous improvement.
Manages established supplier reporting systems and prepares supplier performance metrics and risk determination in alignment with CSI global standards.
Develops content and ensures execution and maintenance of supplier quality agreements.
Coordinates the scheduling of supplier audits and serves as an audit team member, as required.
Leads management and evaluation program for supplier change notifications and complaint/corrective actions.
Represent Supplier Quality function during internal and external audits and management reviews.
Manage 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 activities.
Maintain a healthy quality system while standardizing processes across all facilities.
Build and reinforce a Culture of Quality in a continuous improvement environment.
Qualifications:
Bachelor's Degree or equivalent in Engineering preferred
Required Skills:
10+ years of experience in medical device/pharma industry. Experience to include ISO 13485, 21 CFR 820, MDD 93/42/EEC, EU MDR 2017/745, and MDSAP are minimally required.
5+ years of experience managing and developing staff (local or remote).
Experience with quality systems in a global shared service model preferred.
Advanced level experience using MasterControl, Compliance Wire, and/or other LMS and eQMS software.
Advanced level experience using advanced Microsoft Office and Project Management Tools (Word, PowerPoint, Excel, Access, Teams, Smartsheets, etc.).
Lead Auditor Certified.
Strong knowledge of medical device supplier quality management and regulatory requirements.
Thorough knowledge of applicable regulations, such as ISO 13485:2016 and 21CFR820.
Proficient in PPAP, CAPA, Auditing and Quality Agreements.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.