Associate Director, Device Supplier Management
Merck, Rahway, NJ, United States
Position Overview
As a member of the Device Quality & Regulatory QMS group, the Associate Director will lead initiatives to support QMS Purchasing Controls and Device Supplier Management objectives, building QMS capabilities that impact business processes, systems, and data.
Primary Activities
Work on all purchasing control phases for MDCP suppliers: planning, supplier evaluations/audits, supplier selection/qualification, quality agreements, supplier monitoring and re‑evaluation, maintenance, and sustainability.
Develop and implement phase‑appropriate supplier controls for early commercialization to effectively support MDCP programs in Development.
Support Supplier Audits, acting as Medical Device SME.
Partner with MDCP sites and internal stakeholders to investigate supplier‑caused deviations and CAPAs.
Integrate Purchasing Control Activities into the Integrated Project Plan for each MDCP Program with target dates for execution.
Support development of company supplier device specifications based on intended use and user needs, including defining requirements for quality, technical, commercial, and supply (shelf life, critical attributes, essential performance, etc.).
Collaborate with Procurement for device components, medical devices, and MDCPs to ensure all cGMP Purchasing Control requirements are met.
Participate in supporting MDCP cGMP and quality issues related to pure Medical Devices and the device constituent parts of Combination Products.
Manage activities within electronic computer systems (e.g., Material Management Systems (SAP), Document Management Systems (Veeva Vault), Supplier Management Systems).
Support MDCP sites with new/revised QMS Quality Standards and/or Global Procedures.
Perform related duties as assigned.
Skills
Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR 2017/745, and ISO 13485:2016 for review of Quality Management System documents.
Previous experience in Medical Device and/or Medical Device Combination Products end‑to‑end Supplier Quality Management activities and supplier auditing.
Strong knowledge of the listed regulations and ability to identify gaps in QMS documents.
Knowledge of the design, manufacture, packaging, purchasing, testing, release, storage, and distribution of medical devices and/or combination products.
Ability to build relationships within a team environment.
Experience using computer systems for Quality Management Systems.
Experience authoring, reviewing, and approving Quality Management System documents.
Solid organizational skills with attention to detail and multi‑tasking.
Effective people skills and ability to work collaboratively across diverse teams.
Effective written and oral communication skills.
Qualifications
B.S. and/or M.S. degree in an appropriate Science or Engineering discipline with a minimum of 8 years of experience, including at least 4 years in Supplier Quality Management System/Purchasing Controls and managing external partners/suppliers.
Required Skills
Adaptability
Combination Products
Design Controls
Detail‑Oriented
Employee Training
GMP Auditing
GMP Compliance
GMP Guidelines
Good Manufacturing Practices (GMP)
Influencing Skills
Manufacturing Processes
Medical Devices
Purchasing Management
Quality Management Systems (QMS)
Regulatory Compliance
Risk Management
Strategic Planning
Supplier Quality Management
Supplier Relationship Management
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
Compensation & Benefits The salary range for this role is $129,000.00 – $203,100.00. The role may include eligibility for an annual bonus and long‑term incentive. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days, and other insurance coverage.
Work Model & Other Details Effective September 5, 2023, employees in office‑based U.S. positions will work a hybrid model: three on‑site days per week (Monday‑Thursday) with Friday remote, unless business needs require otherwise. This model does not apply to field‑based, facility‑based, manufacturing‑based, research‑based, or collective‑bargaining agreement positions.
Location This position is open to U.S. and Puerto Rico residents only. Candidates from San Francisco and Los Angeles may be considered in accordance with local fair‑chance laws.
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Primary Activities
Work on all purchasing control phases for MDCP suppliers: planning, supplier evaluations/audits, supplier selection/qualification, quality agreements, supplier monitoring and re‑evaluation, maintenance, and sustainability.
Develop and implement phase‑appropriate supplier controls for early commercialization to effectively support MDCP programs in Development.
Support Supplier Audits, acting as Medical Device SME.
Partner with MDCP sites and internal stakeholders to investigate supplier‑caused deviations and CAPAs.
Integrate Purchasing Control Activities into the Integrated Project Plan for each MDCP Program with target dates for execution.
Support development of company supplier device specifications based on intended use and user needs, including defining requirements for quality, technical, commercial, and supply (shelf life, critical attributes, essential performance, etc.).
Collaborate with Procurement for device components, medical devices, and MDCPs to ensure all cGMP Purchasing Control requirements are met.
Participate in supporting MDCP cGMP and quality issues related to pure Medical Devices and the device constituent parts of Combination Products.
Manage activities within electronic computer systems (e.g., Material Management Systems (SAP), Document Management Systems (Veeva Vault), Supplier Management Systems).
Support MDCP sites with new/revised QMS Quality Standards and/or Global Procedures.
Perform related duties as assigned.
Skills
Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR 2017/745, and ISO 13485:2016 for review of Quality Management System documents.
Previous experience in Medical Device and/or Medical Device Combination Products end‑to‑end Supplier Quality Management activities and supplier auditing.
Strong knowledge of the listed regulations and ability to identify gaps in QMS documents.
Knowledge of the design, manufacture, packaging, purchasing, testing, release, storage, and distribution of medical devices and/or combination products.
Ability to build relationships within a team environment.
Experience using computer systems for Quality Management Systems.
Experience authoring, reviewing, and approving Quality Management System documents.
Solid organizational skills with attention to detail and multi‑tasking.
Effective people skills and ability to work collaboratively across diverse teams.
Effective written and oral communication skills.
Qualifications
B.S. and/or M.S. degree in an appropriate Science or Engineering discipline with a minimum of 8 years of experience, including at least 4 years in Supplier Quality Management System/Purchasing Controls and managing external partners/suppliers.
Required Skills
Adaptability
Combination Products
Design Controls
Detail‑Oriented
Employee Training
GMP Auditing
GMP Compliance
GMP Guidelines
Good Manufacturing Practices (GMP)
Influencing Skills
Manufacturing Processes
Medical Devices
Purchasing Management
Quality Management Systems (QMS)
Regulatory Compliance
Risk Management
Strategic Planning
Supplier Quality Management
Supplier Relationship Management
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
Compensation & Benefits The salary range for this role is $129,000.00 – $203,100.00. The role may include eligibility for an annual bonus and long‑term incentive. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days, and other insurance coverage.
Work Model & Other Details Effective September 5, 2023, employees in office‑based U.S. positions will work a hybrid model: three on‑site days per week (Monday‑Thursday) with Friday remote, unless business needs require otherwise. This model does not apply to field‑based, facility‑based, manufacturing‑based, research‑based, or collective‑bargaining agreement positions.
Location This position is open to U.S. and Puerto Rico residents only. Candidates from San Francisco and Los Angeles may be considered in accordance with local fair‑chance laws.
#J-18808-Ljbffr