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:
Support post market activities and other quality tasks for the Emergency Care and Resuscitation business unit. These activities focus on the process for global medical device reporting to competent authorities and includes review and evaluation quality complaints for fielded product which may represent reports of adverse events and/or critical device malfunctions and timely processing of the reports required for compliance to global regulations and standards.
You will be responsible for:
Handle the receipt, processing, monitoring, and reporting of product defect complaints, Make MDR determination, investigate document the all activities creating the summaries of the investigation
Document product complaints into the database for trending and analysis and ensure the complaint process was completed in accordance with corporate procedures, follow the complaint file all the way until completion
Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Interfaces with Customer Service and customers/patients to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation, ensures that complaints from multiple sources are tracked.
Determines product and incident complaint codes based on the master symptom code severity list.
Applies knowledge of device regulatory requirements in order to support the Post Market Clinical Surveillance reporting process and evaluates complaints for reporting, partners with other departments to resolve product problems and provides feedback to customers as needed, assists with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure, Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
Reviews and complies with all applicable company policies and procedures, local, state, and federal laws and regulations.
CAPA support in response to audit readiness findings and in preparation for audits. Coordinate initiative to close out overdue Field Change Orders with global markets. Provide team members with training on a variety of assignments. Prepare presentations for weekly management/steering committee meetings.
To succeed in this role, you should have the following skills and experience:
3 - 5 years of experience in a medically regulated and technical environment in (FDA Class I or II equivalent – Class III a plus)
Bachelor's /Master's degree or equivalent. Expert and Technical Lead in role.
Experience working in databases such as TrackWise, SAP, OneEMS/Salesforce, ServiceMax - Highly Preferred
Demonstrated strong results orientation.
Proficiency using office tools such as Microsoft Access and Excel, and various other computer software applications.
Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
Requires the proven ability to consistently meet and/or exceed goals. Must be capable of making commitments, setting priorities, and delivering results on time and on budget. Effective team building skills.
Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
You will be a part of:
You are empowered to use your voice and expertise to have a positive impact on your team, the business, and health technologies that will improve the health, well-being and care for people around 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.