Associate Director, Quality Systems & Compliance - Purchasing Controls - Remote

Merck; West Point (NE); Remote; USD 140,000 - 200,000; Full time

Job summary

A leading company in medical devices is seeking an Associate Director for Quality Systems & Compliance. The position involves leading supplier qualifications, managing quality risks, and ensuring compliance with regulatory standards. Ideal candidates will have extensive experience in Supplier Quality Management and hold a B.S. in a relevant field. This role offers competitive salary, bonus opportunities, and a flexible hybrid work model.

Benefits

Comprehensive healthcare benefits

Retirement benefits

Paid holidays

Flexible hybrid work model

Qualifications

• Minimum 8 years experience in pharmaceutical or medical device industry.
• At least 4 years managing Purchasing Controls.
• Strong knowledge of US FDA regulations.

Responsibilities

• Lead supplier qualification and monitoring processes.
• Conduct Quality/Compliance Risk Assessments.
• Manage activities within electronic systems like SAP and Veeva Vault.

Skills

Effective communication

Supplier Quality Management

Quality Risk Assessment

Regulation knowledge

Education

B.S. in Science or Engineering

Tools

SAP

Veeva Vault

Job description

Associate Director, Quality Systems & Compliance - Purchasing Controls - Remote

Employer Industry: Medical Devices

Why consider this job opportunity:
- Salary up to $199,100
- Bonus eligibility and long-term incentive opportunities
- Comprehensive healthcare and insurance benefits for employees and their families
- Retirement benefits, paid holidays, vacation, and sick days
- Opportunity for career advancement and growth within the organization
- Flexible hybrid work model with remote working options

What to Expect (Job Responsibilities):
- Lead and participate in supplier qualification, evaluation, and monitoring processes
- Support supplier audits and investigations related to supplier-caused deviations and CAPAs
- Integrate Purchasing Control Activities into Integrated Project Plans for MDCP Programs
- Conduct Quality/Compliance Risk Assessments and develop Quality Risk Management Plans
- Manage activities within electronic computer systems such as SAP and Veeva Vault

What is Required (Qualifications):
- B.S. in an appropriate Science or Engineering discipline
- Minimum of 8 years of experience in pharmaceutical or medical device Supplier Quality Management
- At least 4 years of experience in Purchasing Controls and managing external partners/suppliers
- Strong knowledge of regulations including US FDA 21 CFR Part 4 and Part 820, EU MDR, and ISO 13485
- Effective written and oral communication skills, with the ability to work collaboratively across teams

How to Stand Out (Preferred Qualifications):
- Experience in Medical Device Combination Products E2E Supplier Quality Management activities
- Familiarity with Quality Management System documents and authoring/reviewing processes
- Proven ability to build relationships in a team environment
- Working knowledge of regulatory expectations for medical device design, manufacture, and distribution
- Experience using computer systems for Quality Management Systems

#MedicalDevices #QualityManagement #CareerOpportunity #HybridWork #SupplierQualityManagement

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About the company

Merck & Co., Inc.,

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