Product Complaints Engineer - Team Lead
Product Complaints Engineer - Team Lead
Posted on :
11-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
DEKA R&D has an immediate opening for a Product Complaints Engineer Team Lead to work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager. This is a high visibility role with a significant direct impact in the Quality Management System.
How you will make an impact:
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.
How you will make an impact:
- Will lead a small team of Product Complaints Engineers focused on one or more of DEKAs innovative lifechanging medical devices.
- Responsible for reviewing complaints related to potential devicerelated issues.
- Perform product complaint evaluations with minimal direction utilizing experience and product knowledge.
- 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.
- Identify and make sound decisions regarding medical device reporting to regulatory agencies.
- Interface with Third Party Manufacturers health care professionals internal customers and regulatory agencies.
- Participate in audits and CAPA investigations as they relate to complaint handling.
- Work with the forensic investigation team to align product investigations related to complaints.
- Track complaint processes to identify areas of improvement.
- Author procedures and work instructions.
- Establish and maintain a product training program.
- Contribute independently while also collaborating with other team members and departments.
- Maintain positive and cooperative communication with coworkers customers contractors and vendors.
- Perform other related duties as assigned under management supervision.
- 4year engineering degree preferably in biomedical engineering and 3 year(s) relevant experience in a cGMP environment supporting complaint handling investigations medical device reporting or product analysis; OR 2year degree and 5 year(s) relevant experience in a cGMP environment supporting complaint handling investigations medical device reporting or product analysis.
- Knowledge of FDA requirements for Quality Systems pharmaceutical products and Medical Device Reporting regulations 21 CFR 803 820 and 211 is preferred.
- 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:
Senior IC
Employment Type
Full-Time
Key Skills
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