Product Complaints Specialist
Product Complaints Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
How you will make an impact:
- Responsible for reviewing and entering complaint information related to potential medical device issues.
- Generate requests for additional information to complete complaint evaluations.
- Perform product complaint evaluations independently while also collaborating with other team members.
- Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements.
- Interface with Third Party Manufacturers health care professionals internal customers and regulatory agencies.
- Influence the creation of new procedures and work instructions.
- Maintain positive and cooperative communication with coworkers customers contractors and vendors.
- Perform other related duties as assigned under management supervision.
- 1 year(s) work experience in a cGMP related industry or in a clinical setting is preferred.
- Knowledge of FDA requirements for Quality Systems pharmaceutical products and Medical Device Reporting regulations 21 CFR 803 820 and 211
- Experience with SalesForce is preferred.
- Strong motivation to see individual tasks through to completion and to help as needed to achieve team goals.
- Exceptional time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures.
- Good problemsolving and proficient computer skills are required.
- Solid written/verbal communication and organizational skills as well as attention to detail.
- Sound technical writing skills.
- Ability to work well independently and on crossfunctional teams in a fastpaced changing environment.
One hour from the beach Boston and the mountains the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development where we are taking the same innovation and cuttingedge technology into the modern age.
Behind DEKAs brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering design and manufacturing. Here at DEKA some of the most innovative and lifechanging products of our time are created and new ideas are always welcome and explored.
Required Experience:
Manager
Employment Type
Full-Time
