Senior Specialist, Medical Device Combined Product

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Reporting to the Director CDQ systems, the Quality Assurance Medical Device | Combined Product Senior Specialist this role is primarily accountable for supporting Medical Device and Combination Product (MDCP) Complaints processing and reporting. This position partners closely with Complaint Investigating Units (CIUs) and cross functional teams across the organization. Activities include but are not limited to develop, review and approve complaints and MDCP documentation to ensure compliance with all applicable Medical Device Regulations and our Company internal requirements. Additionally this position is accountable for planning and execution of MDCP projects as well as support of the associated processes and systems.

**Responsibilities**
- Review reportable external customer complaints, upon intake, for appropriateness for health authority submission
- Document review/approval in complaint IT system
- Partner with the site CIUs, MDCP Ops, Technical, Safety and PV groups to ensure robust CAPAs are put in place, and the design of the device and device components are adequately considered when manufacturing or packaging root causes are not identified
- Review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented, and collaborate with Technical and Safety groups to update risk Risk Files
- Review and approve reportable external customer complaint investigation reports prior to their submission to health authorities
- Assist with other reporting and trending/analytic requirements, including but not limited to PMPR, PAER, AMR, high risk quarterly and monthly product trending

**Education**
- Bachelor degree in Science or Engineering or associated fields

**Required**
- Minimum five years related experience
- Strong working knowledge of applicable medical device and combination product regulations (21CFR820, 21CFR Part 4 including Post Market Safety Reporting requirements, EU MDR, ISO 13485), Risk Management Experience (ISO 14971)
- Work effectively in high performance cross functional teams
- Principled verbal and written communications, collaboration, leadership, technical writing and review skills
- Ability to work in a matrix organization, operate independently with flexibility to adapt to fast paced environment with changing priorities
- Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition
- High degree of critical thinking, resourcefulness, and networking required to coordinate projects and resolve process and system issues that can span functional groups across the divisions
- Solid problem solving and decision-making abilities with attention to detail and continuous improvement mindset

**Preferred**
- Complaint handling investigation process for medical devices and combination products
- Operating in complaints IT system/database
- Medical device and combination product Design Controls, Device Risk Management

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

**Who we are **
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for **
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

**NOTICE FOR INTERNAL APPLICANTS**

If you have been offered a separation benefits package, but have not yet reach