Post Market Surveillance
Post Market Surveillance (Randstad Contingent Worker)
Actual Job Title - Post Market Surveillance Consultant II
This in an onsite hybrid role at the Carlsbad, CA location.
In this role, you will have the opportunity to:
Support post market activities and other quality tasks for the Hospital Respiratory Care 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 products 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:
- Evaluate, investigate, track and complete complaints through an effective and established complaint handling process.
- Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
- Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.
- Coordinate with the reportable complaint investigators in providing any missing information for root cause activities.
- Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate initial evaluation of complaints.
- Collaborate with Adverse Event Coordinators for reportable complaints as well as Product Safety Committees for Correction and Removal process.
- Work with the Post Market Surveillance for any other projects assigned.
To succeed in this role, you should have the following skills and experience:
- Bachelor Degree in science, health care, engineering/electrical, nursing, EMT-B, or related field, or relevant years work experience.
- Minimum 2-5 years of experience in a medically regulated and technical environment in (FDA Class I or II equivalent – Class III a plus)- Highly Preferred
- Experience working in databases such as TrackWise, SAP, OneEMS/Salesforce, ServiceMax, TrackWise - 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:
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.