Sr. Specialist, Medical Device Combination Product (MDCP) Quality job in West Point
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|Employer:|| Merck & Co.|
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. |
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Reporting to the Director MDCP Quality Systems and Compliance, lead responsibilities include:
• Author standard operating procedures, forms and templates
• Manage documents in the electronic computer systems throughout their life cycle
• Create training materials for documents within MDCP Quality curricula
• Manage activities within electronic computer systems, e.g. TrackWise, SAP, Success Factors (LMS), etc.
• Assist with system support and record management.
• Maintain document and data integrity in electronic computer systems.
• Plan and coordinate MDCP Quality meetings (i.e.; Change Control, CAPA, Deviation Management, etc.) and manage meeting minutes, records and documents.
• Collect, analyze quality metric data for management reviews.
• Oversee MDCP Quality mailbox and Sync Page for timely responses
• Collaborate with teams across cultures at all levels and foster continuous improvements
• Participate in SAP Data Governance Community of Practice as MDCP Quality Data Steward.
• Support local MDCP sites with new/revised SAP Material Masters with MDCP identifiers.
Education Minimum Requirement:
• Bachelor's degree in Regulatory Affairs or Quality Assurance or Engineering
•At least 5 years' experience with medical devices and/or medical device combination products
Required Experience and Skills**:
• Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR:2017 and ISO 13485:2016 for review of Quality Management System documents for Merck's Quality Manual.
• Must have strong knowledge of regulations listed above and be able to work in a team environment identifying gaps in the QMS documents
• Must be able to build relationships within a team environment
• Experience using computer systems for Quality Management Systems
• Must have working knowledge of regulatory expectations for the design, manufacture/packaging and distribution of medical devices or medical device combination products with experience in quality assurance or regulatory oversight of these products
• Experience authoring, reviewing and approving Quality Management System documents
• Solid organizational skills including attention to detail and multi-tasking skills
• Effective interpersonal skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in others
• Effective written and oral communicator, ability to speak up and contribute in a team forum
Preferred Experience and Skills:
• Working knowledge for the design, manufacture, packaging, testing, release, storage and distribution of medical devices and/or medical device combination products
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Visa sponsorship is not available for this position.
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