Product Complaints Engineer - Team Lead

DEKA Research & Development; United States; On-site; USD 100,000 - 150,000; Full time

Job summary

DEKA Research & Development is seeking a Product Complaints Engineer - Team Lead to guide a small team in a dynamic Medical Device environment. You will review complaints related to potential device-related issues and perform evaluations with minimal direction.

The role ensures documentation follows Good Documentation Practices, complies with FDA regulations, and interfaces with manufacturers, health care professionals, and regulators.

Qualifications

• Requires a 4-year engineering degree (Biomedical preferred) with 3+ years in a cGMP environment or a 2-year degree with 5+ years in cGMP.
• Knowledge of FDA Quality System Regulations (21 CFR 820, 803, 211) and related reporting.
• Experience with Salesforce is preferred.
• Must show motivation to complete tasks and support team goals.
• Exceptional time management to handle multiple projects and comply with SOPs.
• Strong problem-solving and computer skills are required.
• Excellent written and verbal communication and organizational abilities.
• Solid technical writing skills.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Lead a small team of Product Complaints Engineers focused on medical devices.
• Review complaints related to potential device-related issues.
• Perform product complaint evaluations with minimal direction.
• Ensure complaint documentation follows Good Documentation Practices and FDA regulations.
• Identify and decide on medical device reporting to regulators.
• Interface with Third Party Manufacturers, health care professionals, and regulators.
• Participate in audits and CAPA investigations related to complaints.
• Coordinate with forensic investigations for product-related complaints.
• Track complaint processes and identify areas for improvement.
• Author procedures and work instructions.
• Establish and maintain a product training program.
• Contribute independently and collaboratively with teams.
• Maintain professional communication with coworkers, customers, contractors, and vendors.
• Perform other duties as assigned by management.

Skills

Biomedical engineering degree

cGMP experience

FDA regulatory knowledge

Salesforce experience

time management

problem solving

written/verbal communication

organizational skills

technical writing

independence & teamwork

Education

4-year engineering degree (biomedical preferred)

2-year degree + 5+ years relevant experience

Tools

Salesforce

Job description

DEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Product Complaints Engineer - Team Lead to work in a dynamic Medical Device 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:

• 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.

About Millyard Advanced Medical Products:

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 (https://www.dekaresearch.com/)
• Contract Manufacturer:Merrimack Manufacturing (https://merrimackmanufacturing.com/)

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.