Post Market Surveillance Consultant

Post Market Surveillance Consultant (Randstad Contingent Worker)

This position will be fully remote and can be home-based from anywhere in the US.  

In this role, you will have the opportunity to:

The Post Market Surveillance Consultant will support post market activities for Precision Diagnostics.  

You will be responsible for:

• Development and deployment of standardized Correction & Removal process for Precision Diagnosis

• Drafting and review of procedures, work instructions, and templates

• Development of training materials

• Participate in/Lead C&R Improvement Projects

To succeed in this role, you should have the following skills and experience:

At least 5 years experience working in medical device quality and regulatory environment, with strong working knowledge of 21 CFR 820 (Quality System Regulation) and ISO 13485 (Medical Device – Quality Management Systems)

Expert working knowledge of applicable global medical device recall regulations and standards, including:

21 CFR Part 806 (Medical Devices: Reports of Corrections and Removals)

21 CFR Part 7 (Enforcement Policy – Recalls)

MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System)

Working knowledge of QMS sub-system feeder processes that interface with C&R (such as Complaint Handling, CAPA, Post-Market Surveillance, Risk Management, Control of Nonconforming Product)

Strong written and verbal communication skills

Experience drafting standard operating procedures, work instructions, and templates

Experience developing training materials to support process implementation

Experience in data analysis and presenting data in a manner to drive informed decision making

Ability to effectively develop and deliver presentations to various levels within the organization

Proficient in Microsoft Word, Excel, PowerPoint and familiar with Project management tools (e.g. MS Project)

You will be a part of:

An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.

In return, we offer you:

Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.

Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
 

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.