Product Complaints Engineer - Team Lead

DEKA Research & Development; Manchester (NH); On-site; USD 70,000 - 90,000; Full time

Job summary

DEKA Research & Development is seeking a Product Complaints Engineer - Team Lead to enhance the Quality Management System for medical devices. The successful candidate will lead a team, evaluate product complaints, and ensure compliance with FDA regulations.

This role requires a background in engineering with significant experience in complaint handling within a cGMP environment. Candidates with strong communication skills and a detail-oriented mindset will thrive in this dynamic position.

Qualifications

• Minimum 3 years relevant experience in a cGMP environment.
• Knowledge of FDA requirements for Quality Systems.
• Ability to work on cross-functional teams.

Responsibilities

• Lead a small team of Product Complaints Engineers.
• Review complaints related to medical devices.
• Track complaint processes to identify improvement areas.

Skills

Biomedical engineering

Complaint handling investigations

Time management

Problem-solving

Education

4-year engineering degree

2-year degree with relevant experience

Tools

SalesForce

Job description

DEKA R&D, on behalf of Millyard Advanced Technologies, 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 Technologies

• Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.