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MDR Supplier Lead

Lancesoft Inc.
West Chester, Pennsylvania, United States
June 13, 2019


Location: West Chester, PA



• Manage the Key Deliverables for External Manufacturing for the MDR program from concept through execution.

• The Supplier Lead role is to lead External Manufacturing activities for MDR project to ensure that MDR compliance is achieved without any service disruption to customers or significant cost implications to the business.

• The SRM ensures that the Synthes suppliers provide purchased finished goods, direct and indirect materials or services that align with DPS, J&J, Global Regulations and industry standards.

• Using a risk-based approach, the SRM handles the MDR Readiness Control Process and leads the Supplier Engagement Workstream for MDR.

The SRM role is to plan and manage large-scale business MDR programs/projects within a global matrix organization.

This includes project planning, execution, implementation and on-going support.

The SRM will work with the functional business leads to ensure the efficiency and effectiveness of the solution deployed in support of the business goals and objectives.


• Accountable for the successful delivery of multiple simultaneous key activities, spanning multiple functional areas and locations.

• Responsible of clear definition of project scope and deliverables, milestones and timeline, risk management and contingency plans through expert communication and leadership skills to establish a common understanding of the project expectations on delivery

• Schedules and facilitates project status meetings and advises management on project status, risk and mitigation including executive reporting. Facilitates problem resolution.

• Communicates project implementation options, schedule, quality and risk to stakeholders, as well as offer recommendations based on these elements.

• Plan, schedule and track project timelines using appropriate tools.

Key Tasks

• Manage supplier engagement & communication for applicable supplier scope (Synthes supplier base)

• Conduct MDR supplier risk categorization

• Use supplier risk categorization to work with Product Execution Leadership Team (PELT) and SELT team to update cadence and ensure work packets initiated early for priority/ high risk codes

• Where necessary, negotiate an agreement to ensure that MDR compliance is achieved on time through a solution that optimizes service, inventory and cost.

• Support Supplier Quality for Tech File readiness – including Material and Product Information & Risk Management Activities for all related suppliers

• Manage suppliers for change control execution for MDR – includes coordinating with SQ, Tech Ops, Labelling, Packaging

• Manage supplier for supply chain readiness – work with External Operations and Supply Chain Planning to determine and execute supply strategy at code level

• Provide input to SKU level supply chain readiness execution plan

• Plan, schedule and track supplier activities and timelines using appropriate tools

• Schedule & facilitate risk status meetings with the aim to advise Core Team on project status, risk and mitigation

• Partner with Procurement, Manufacturing and R&D to manage and mitigate supplier risk across the product lifecycle.

• Ensure you make appropriate resource and budget and allocation decisions. Takes a leadership role in engaging key partners to scope projects, resources, budgets and timelines to ensure execution.

• Ensures compliance to applicable Global Regulations and standards (e.g QSR, ISO, EN, and Medical Device Regulation (MDR) requirements).


• Connect with and coordinate the Synthes supplier base

• Holds self and people accountable for results achieved through the Johnson & Johnson Credo Values and Leadership Imperatives. Removes barriers to people development. Models and fosters people development. Actively champions and supports people development to expand their capabilities, skills, knowledge and enable movement of talent.


• 2+ years’ experience managing business projects and/or supplier relationships

• 2+ year’s experience with project management tools, e.g., MS Project

• Proven exceptional written and oral presentation skills

• Demonstrated ability to lead across multiple business organizations, including global and enterprise-wide projects.

• Experience in an Medical Device regulated environment


• Bachelor’s degree in business, information systems or related discipline, or equivalent and extensive related project experience.

• Certificates in Program/Project Management will enhance candidacy but are not a requirement


• Strong knowledge and skills in MS Office

• Must be highly organized, creative, articulate and analytical

• Strong interpersonal and diplomatic skills

• Ability to multi-task independently with minimal supervision

• Must have solid understanding of project management methodologies


• Must be able to work on multiple simultaneous tasks with limited supervision;

• Quick learner, motivated self-starter;

• Excellent customer service, interpersonal, communication and team collaboration skills;

• Able to follow change management for internal guidelines. Language proficiencies:

• English spoken and written; German, French & Italian is a plus.