Product Complaints Engineer - Team LeadDEKA Research & Development • Manchester, NH, US
Product Complaints Engineer - Team Lead
DEKA Research & Development • Manchester, NH, US
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
- [filters_job_card.quick_apply]
[job_card.job_description]4-year 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 2-year 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 problem-solving 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 cross-functional teams in a fast-paced, 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 cutting-edge technology into the modern age. Behind DEKA’s 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 life-changing products of our time are created, and new ideas are always welcome and explored. Powered by JazzHR
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 :
- Will lead a small team of Product Complaints Engineers focused on one or more of DEKA’s innovative, life-changing medical devices.
- Responsible for reviewing complaints related to potential device-related 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 co-workers, customers, contractors, and vendors.
- Perform other related duties as assigned under management supervision.
Skills needed to be successful :
About DEKA :
[job_alerts.create_a_job]
Lead Product Engineer • Manchester, NH, US
[internal_linking.related_jobs]
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 Complain...[show_more]
A company is looking for a Technical Customer Support Specialist.Key Responsibilities Triaging customer issues and debugging problems related to the AI platform Collaborating with engineering an...[show_more]
Bruker, a world leader in analytical instrumentation, is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life.Bruker's high-perfo...[show_more]
The Technical Account Management Team proactively supports our customers in meeting their goals and overcoming any technical challenges encountered using the Relativity suite of products.As a membe...[show_more]
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.
We guarantee 15-25 hours per week with an hourly pay of bet...[show_more]
The company is a leading commercial contractor specializing in Division 8 products and services.They have built a reputation for delivering turn-key solutions through their collaborative Product an...[show_more]
We’re offering a role for someone who wants to lead their own side-income project in their spare time.You’ll explore various proven side hustles, select the ones that fit your lifestyle, and run th...[show_more]
We want you to help us shape the future of shopping experiences and deliver on our purpose of connecting people with the products and experiences that enrich their lives.
Joining SAS Retail Services...[show_more]
As a Recruiting Team Lead , you will lead a team of recruiters, leveraging multi-faceted delivery strategies to meet customer needs.
This is a player-coach position with individual goals for prospec...[show_more]
This role supports workflow efficiency by coordinating with leadership and team members, diagnosing and repairing tools, documenting processes, and providing training.
It also involves monitoring te...[show_more] A company is looking for a Customer Support Engineer who will bridge communication between customers and technical teams.
Key Responsibilities Serve as a primary technical contact for customers, i...[show_more] A company is looking for a Senior Manager, Global Customer Support.Key Responsibilities Manage and mentor a team of support professionals to ensure high-quality customer interactions Oversee sup...[show_more] 
Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.Architecture & Design Support.
Support the definition of system and data integr...[show_more]
Join a Team That Moves with Purpose.Are you looking for a fast-paced, hands-on role where your work truly matters? At Milton CAT, our Order Fulfillment Associates are the heartbeat of our distribut...[show_more])
WHEN YOU WORK FOR US, WE WORK FOR YOU.With Titan Medical, you gain access to thousands of travel nursing and allied health jobs across the country.
You also get unmatched service.From the moment you...[show_more]
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally.At Getinge we exist to make life-saving technology accessible for more people....[show_more] We are seeking a Lead Software Engineer to join the Retrieval Ingestion Team at Relativity.This role is ideal for an experienced engineer who thrives on designing and operating high throughput inge...[show_more] 
Join Our Squad and Make Memories!.Hey there, go-getters and adventure seekers! Ready to dive into a job that's all about turning everyday moments into unforgettable memories? We're on the hunt for ...[show_more]
Product Complaints Engineer - Team Lead
DEKA Research and Development • Manchester, NH, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Technical Customer Support Engineer
VirtualVocations • Manchester, New Hampshire, United States
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Customer Support Engineer
Bruker • Billerica, MA, United States
[job_card.full_time] +1
[last_updated.last_updated_variable_days] • [promoted]
Senior Technical Account Manager
Relativity • Manchester, NH, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Test Products from Home – $25-$45 / hr + Freebies
OCPA • Belmont, New Hampshire, us
[job_card.part_time] +1
[last_updated.last_updated_30] • [promoted]
Project Engineer / Detailer-Commercial Door &Hardware
Kimmel and Associates • Wilmington, MA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Side Hustle Project Lead
Finance Buzz • Loudon, New Hampshire, US
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Retail Merchandiser Team Lead
SAS Retail Services • Westford, Massachusetts, us
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Team Lead, Recruiting
Medicus Healthcare Solutions • Windham, NH, United States
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Tooling Group Leader
Hubbell Incorporated • Londonderry, NH, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Customer Support Engineer
VirtualVocations • Manchester, New Hampshire, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Senior Customer Support Manager
VirtualVocations • Manchester, New Hampshire, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Solutions Engineer
Keurig Dr Pepper • Burlington, Massachusetts, US
[job_card.full_time]
[last_updated.last_updated_1_day] • [promoted]
Order Fulfillment Associate
Milton CAT • Londonderry, NH, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Travel - Cath Lab Tech
Titan Medical (Nebraska) • Chichester, NH, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Principal Engineer, Design Quality
Getinge • Merrimack, NH, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Lead Software Engineer
Relativity • Manchester, NH, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Crew Member - Fluent in English
Dunkin' - Cafua Mgmt Co A Dunkin' Franchisee Loudon Donuts • Loudon, NH, United States
[job_card.full_time]
[last_updated.last_updated_1_day] • [promoted]