Job Summary:

Responsible for applying diversified technical and management knowledge of Manufacturing, Operations, and Quality exercising acumen of Supply Chain Management to plan, design, and optimize a subcontract outsource manufacturing model. The role identifies, recommends, and implements tactics to ensure minimum risk and maximum scale in support of the company's strategic growth plan.

job responsibilities:

• As Program Manager, develops long-term improvement strategies with suppliers. 
• Validates supplier proposals for improvement makes investment cases, and manages implementation. 
• Focuses on driving improvements in production through automation and other techniques
• Develops and drives a beneficial partnership model with suppliers based on continuous improvement methodologies that yield cost, quality, and service improvements
• Assesses supply chain risk develops risk mitigation strategies and identifies and develops new suppliers as required by ongoing and future business needs
• Program management of supplier’s manufacturing plant transfers and selection/qualification of new suppliers.
• Develops scorecards and leads ongoing supplier performance reviews. 
• Collaborates on process improvement activity with suppliers to ensure industry-leading quality and service
• Collaborates with Design and Quality Engineering functions to investigate and resolve quality or compliance issues at suppliers.  
• Reviews and approves supplier documentation such as Standard Operating Procedures, Critical to Quality characteristics and Control Plans, and Work Instructions.
• Key stakeholder in early supplier involvement efforts, Design for Manufacturability (DFM), PPAP, and is the key liaison between design engineering and the contract manufacturing supply chain.
• Develops and maintains a technology and capacity roadmap that aligns with the company's New Product Development timeline and future revenue growth
• Provides and solicits input from internal and external stakeholders for design, manufacturing, material specifications, and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested.
• Develops, writes, and controls detailed work instructions
• Communicates clearly. 
• Responsible for ensuring all parties understand the direction, and status of all meetings, projects, and development.
• Utilizes metrics, dashboards, and standard reports to communicate status 

QUALIFICATIONS:

Knowledge & Educational Requirements:

• Bachelor’s Degree in an Engineering discipline or equivalent with a minimum of 10 years of experience in Supplier Management for medical devices
• Knowledge of components and core manufacturing processes for CRM or equivalent devices
• Knowledge of Lean Six Sigma concepts
• Experience with standard qualification standards and development tools such as Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), and Measurement System Analysis (MSA) for supplier development

Skills & Abilities:

• Track record of Program Management success including leadership, teamwork, collaboration, creativity, and innovation while effectively communicating across various levels of the organization
• Strong analytical and problem-solving skills.
• Ability to establish collaborative working relationships cross-functionally internally as well as with a diverse supply base
• Self-motivated, results-oriented with strong written and verbal communication skills; ability to effectively prepare and deliver technical reports and presentations

Physical Demands/Work Environment:

• Ability to provide on-site “hands-on” support to suppliers if required
• Ability to travel in support of job function (plants, customers, suppliers, etc.)

General Understanding:

• Knowledge of Quality Management System.
• Working knowledge of standards and regulations as outlined in the QMS documentation and structure.
• Understanding that device defects may occur from the improper performance of specific job functions, including those personnel performing or participating in validations.
• Each country has regulatory requirements which must be adhered to, which can impact individual roles within the company.
• Understanding of individual role in achieving company quality objectives and QMS compliance.