DEKA R&D, on behalf of Millyard Advanced Technologies,is looking for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment. The position reports to ...
DEKA
35 Deka Jobs Hiring Near You
DEKA R&D, on behalf of Millyard Advanced Technologies,is looking for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment. The position reports to ...
Manufacturing Engineer - Mid-Level
Manchester, NH · On-site
$72K - $93K/yr
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.
Manufacturing Engineer - Mid-Level
Manchester, NH · On-site
$72K - $93K/yr
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.
At DEKA, that's not a hypothetical, we like to call it Tuesday! We are developing advanced systems, backed by federal support, designed to produce life-saving fluids at the point of care, deployable ...
At DEKA, that's not a hypothetical, we like to call it Tuesday! We are developing advanced systems, backed by federal support, designed to produce life-saving fluids at the point of care, deployable ...
Electronics Test Technician
Manchester, NH · On-site
$22 - $29.75/hr
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.
Electronics Test Technician
Manchester, NH · On-site
$22 - $29.75/hr
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.
Senior Mechanical Engineer
Manchester, NH · On-site
$104K - $137K/yr
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.
Senior Mechanical Engineer
Manchester, NH · On-site
$104K - $137K/yr
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.
DEKA Research and Development is seeking Robotics Control Systems Engineers (Multiple Openings) to join our engineering team. Job Responsibilities: * Work with a team of Engineers for detecting and ...
DEKA Research and Development is seeking Robotics Control Systems Engineers (Multiple Openings) to join our engineering team. Job Responsibilities: * Work with a team of Engineers for detecting and ...
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.
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.
DEKA Research and Development, on behalf of Millyard Advanced Technologies, located in Manchester, NH, is a dynamic, growing company, focused on the development of new technologies that span a ...
DEKA Research and Development, on behalf of Millyard Advanced Technologies, located in Manchester, NH, is a dynamic, growing company, focused on the development of new technologies that span a ...
Machine Learning Engineer
Manchester, NH · On-site
This role is on-site at DEKA in Manchester, NH. Relocation is not available, local candidates only. How You Will Make an Impact: * Design and implement scalable backend services and microservices ...
Machine Learning Engineer
Manchester, NH · On-site
This role is on-site at DEKA in Manchester, NH. Relocation is not available, local candidates only. How You Will Make an Impact: * Design and implement scalable backend services and microservices ...
DEKA has an immediate opening for a Project Manager, Post Market Products to support and coordinate post market surveillance and product quality activities in a dynamic medical device research and ...
DEKA has an immediate opening for a Project Manager, Post Market Products to support and coordinate post market surveillance and product quality activities in a dynamic medical device research and ...
Systems Engineer
Manchester, NH · On-site
DEKA Research & Development is seeking a dynamic, results-driven, and inventive Systems Engineer to join the development of groundbreaking medical technologies. This is a rare opportunity to apply ...
Systems Engineer
Manchester, NH · On-site
DEKA Research & Development is seeking a dynamic, results-driven, and inventive Systems Engineer to join the development of groundbreaking medical technologies. This is a rare opportunity to apply ...
DEKA Research and Development is seeking a Junior Control Systems Engineer to join our engineering team. In this role, you will contribute to the design and development of cutting-edge automation and ...
DEKA Research and Development is seeking a Junior Control Systems Engineer to join our engineering team. In this role, you will contribute to the design and development of cutting-edge automation and ...
Supplier Quality Engineer
Manchester, NH · On-site
The SQE serves as a key technical and quality liaison between the DEKA design team and manufacturing partners with primary responsibility for ensuring suppliers are capable of consistently meeting ...
Supplier Quality Engineer
Manchester, NH · On-site
The SQE serves as a key technical and quality liaison between the DEKA design team and manufacturing partners with primary responsibility for ensuring suppliers are capable of consistently meeting ...
The Sr. SQE serves as a key technical and quality liaison between DEKA, manufacturing partner and its supplier base, with primary responsibility for ensuring suppliers are capable of consistently ...
The Sr. SQE serves as a key technical and quality liaison between DEKA, manufacturing partner and its supplier base, with primary responsibility for ensuring suppliers are capable of consistently ...
Process Controls Engineer - Integrated Clean Environments
Manchester, NH · On-site
$83K - $107K/yr
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.
Process Controls Engineer - Integrated Clean Environments
Manchester, NH · On-site
$83K - $107K/yr
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.
DEKA Jobs Information
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Full-time
Posted 22 days ago
Job description
DEKA R&D, on behalf of Millyard Advanced Technologies,is looking for a Product Complaints Engineer 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:
About Millyard Advanced Technologies:
https://millyardadvanced.com/
Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.
Established 2019
Selected Partners
About DEKA:
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 and 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.
How you will make an impact:
- Responsible for reviewing complaints related to potential medical device 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.
- Generate reports to identify areas of process improvement.
- Develop product training aids.
- Contribute independently while also collaborating with other team members and departments needing product complaint information.
- Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
- Serve as a subject matter expert on complaint handling.
- Perform other related duties as assigned under management supervision.
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline required.
- Minimum of 3-5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment, with direct responsibility for complaint investigations, product quality investigations, product analysis, and complaint closure activities.
- Demonstrated experience conducting complaint investigations, determining root cause, documenting investigation results, and independently driving records to closure in compliance with established timelines.
- Working knowledge of FDA Quality System Regulations, Medical Device Reporting requirements, and applicable standards, including 21 CFR Parts 803 and 820; experience with ISO 13485 is preferred.
- Experience evaluating product complaints for reportability and supporting regulatory submissions is preferred.
- Experience using electronic quality management systems (eQMS), complaint handling systems, and platforms such as Salesforce is preferred.
- Strong technical troubleshooting, analytical, and problem-solving skills with the ability to assess complex product performance issues and identify potential failure modes.
- Exceptional time management skills with the ability to manage a high-volume complaint workload while meeting regulatory and internal closure targets.
- Excellent technical writing skills with demonstrated ability to prepare clear, concise, and compliant investigation reports.
- Strong written and verbal communication skills with the ability to effectively interact with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Customer Support teams.
- Highly organized, detail-oriented, and self-motivated with the ability to work independently and make sound decisions based on available evidence.
- Ability to thrive in a fast-paced, changing environment while maintaining compliance with regulations, procedures, and quality system requirements.
About Millyard Advanced Technologies:
https://millyardadvanced.com/
Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.
Established 2019
Selected Partners
- Contract Designer: DEKA Research & Development
- Contract Manufacturer: Merrimack Manufacturing
About DEKA:
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 and 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.