Entry-Level Medical Device Tester

PMS Complaint Handling Technician

ONSITE - Linwood, PA 19061

6-Month Contract - Potential to extend or convert FTE

They will be working on 2 product lines for CLIENT. Handling 60 evals per month once they are up and running

Doing general maintenance as well, inventory management, storing devices, and testing for issues/complaints

They are provided with a list of tests they can perform on the devices, they need to be able to think through each issue and troubleshoot based on the complaint

They will use salesforce to log the complaint and record the testing they performed and issues found

Top must haves:

• Bachelors Degree in Engineering, Biotech, or any other STEM degree (entry level) OR an Associates degree with a couple years of experience
• Experience handling or editing SOP’s, any technical writing/documentation knowledge

Training will be 8am-4:30pm

After training core hours will be 9am-2pm. Contractors can go in as early as 7am and work an 8 hour shift. Earlier is better since this is a distribution facility they are usually shut down by late afternoon

Summary:
Under the supervision of the onsite engineers conduct investigations of suspected non-conforming devices and materials coming from patient and/or clinical reports of failure. Documents the results of investigations within the complaint handling tool. Provides feedback concerning reoccurring issues and escalates complaints when severity has exceeded the documented expected severity of the Risk Management file (RMM). General housekeeping and movement of devices back to the field via the inventory management system. Cleaning and disinfection of incoming suspected non-conforming material in which has an associated complaint.

Job Responsibilities:

• Aids in the management of a dedicated departmental support process which has a direct impact on Client''s med-tech products by collaborating with different stakeholders to ensure smooth operations, demonstrating great inter-personal and communication skills.
• Supports the day-to-day activities of a dedicated department, typically involving hands-on, operational tasks essential for providing technical complaint investigation support to meet dynamic environment and continuous improvement goals, exercising autonomy within established procedures.
• Participates in team meetings, contributing innovative ideas and strategic input, while also capturing detailed minutes that accurately reflect discussions, decisions, and action items, ensuring effective communication and follow-up within the team.
• Assists in preparation and presentation of reports or findings for internal and external stakeholders as required by manager/supervisor, ensuring that all findings are presented with utmost accuracy and clarity.
• Maintains up to date knowledge of industry trends, developments, and best practices and learns technical skills related to industry, exhibiting a commercial and growth mindset. Minimum required

Education:
High School Diploma plus two years of experience, College or Vocational Education a plus. Minimum required Experience: Two years of experience in a regulated environment. Minimum required Certification: N/A Preferred Education: N/A Preferred Experience: N/A Preferred Certification: N/A Preferred Skills: Stakeholder Management Business Acumen Document Management Root Cause Analysis (RCA) Research & Analysis Documentation & Reporting Microsoft Office Technical Acumen