Duration 6 months contract to start with
Location Andover MA
We need someone with some complaints processing experience.
In this role, you have the opportunity to
The Complaint Specialist will manage the complaint investigation process. You will work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.
You are responsible for
• Evaluate, investigate, track and complete complaints through effective and established complaint handling processes.
• Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
• Participate and collaborate objectively with team members to achieve consistent processes while identifying process improvements to drive efficiency and compliance.
• Coordinate with team members in obtaining any missing information.
• Collaborate with a variety of diverse persons such as Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers and Manufacturing personnel to facilitate the complaint investigation process globally.
• Review each complaint and determine eligibility for adverse event reporting to worldwide regulatory agencies.
• Other projects as assigned.
You are a part of
The Patient Monitoring Post Market Surveillance Team is headquartered out of Andover, MA.
Complaint Specialist supporting multiple businesses, including but not limited to, Patient Monitoring and Medical Consumable Suppliers.
The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations.
To succeed in this role, you should have the following skills and experience
• Post-market complaints experience in a medically regulated industry.
• Bachelor’s degree in engineering, clinical sciences, related sciences, or relevant related experience
• Proficiency using office tools such as Microsoft Office Suite and various other computer software applications.
• Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other regulated industry (Pharma, IVD,) preferred.
• An organized, analytical thinker with exceptional attention to detail.
• An excellent communicator, both written and verbal for coordinating with colleagues and regulatory authorities worldwide.
• Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
• Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
• Experience in TrackWise or similar system is preferable.
Experience: Minimum 3 years professional experience in the applicable role.
Handle the receipt, processing, monitoring, and reporting of product defect complaints, Investigate and document all activities creating the summaries of the investigation, Documented product complaints into the database for trending and analysis and ensured the complaint process was completed in accordance with corporate procedures, follow the complaint file all the way until completion, Develop professional expertise, applies company policies and procedures to resolve a variety of issues.
Interfaces with Customer Service and Field Service, 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, 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.
Reviews and complies with the all applicable company policies and procedures.
Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com