Description: This position is essential to the compliance of the company with FDA and international regulatory authorities. This position will be responsible for receiving, evaluating, and processing customer/product complaints for products. This is a very customer-focused position and will have daily interactions with internal and external customers.
Receives and processes customer complaints in accordance with FDA, ISO 13485 and other regulatory from written, electronic, and oral communications are entered the complaint handling database in accordance with procedure. Contacts hospital, physician's office or sales representative to request product returns and additional information to adequately investigate a customer complaint. Coordinates with outside suppliers (CM products) the evaluation response for returned product and documents these findings in the complaint handling database Supports Sr. PMS specialists for complaint investigations such as checking-in returned devices Writes correspondence to the physician's office regarding results and conclusions of the complaint investigation Supports closure of complaint files Work with other Product Evaluation team members to determine prioritization of daily activities. Takes initiative and action to respond, resolve, and follow up on all product complaints in a timely manner. Alerts the Post Market QA Manager of unusual or high-risk events requiring review by Legal or Regulatory Affairs Maintains order, cleanliness, equipment calibration and PE lab supply inventory. Responsible for maintaining complaint files within a secured environment. Creates tailored complaint reports for Corporate, Local Management, Regulatory, Research & Development, and other departments upon request Maintains and retains complaint records in accordance with the US record retention policy Maintains the Implant Registry database Skills: Complaint analysis, biomedical engineering, complaint handling, medical device, Quality
Additional Skills & Qualifications: Bachelor's Degree in STEM Required
Experience in a medical device manufacturing or quality role is desired
Excellent verbal and written English communication skills
Knowledge of ISO 13485
Intermediate level expertise using MS Office applications (Word, Excel, PowerPoint)
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.
