Junior Product Complaints Engineer

DEKA Research and Development; Manchester (NH); On-site; USD 60,000 - 80,000; Full time

Job summary

DEKA Research and Development in Manchester, NH, seeks a qualified individual to assess complaints regarding medical devices. The role requires strong knowledge of FDA regulations and experience with complaint handling. Candidates should possess a biomedical engineering degree and have excellent problem-solving as well as communication skills.

The position offers opportunities to work in a fast-paced environment alongside regulatory agencies and healthcare professionals, ensuring high standards in product evaluations and documentation.

Qualifications

• 4-year biomedical engineering degree or equivalent with relevant experience in a cGMP environment.
• Experience in complaint handling or quality engineering preferred.
• Knowledge of FDA requirements for Quality Systems and Medical Device Reporting.

Responsibilities

• Review complaints related to medical device issues.
• Perform product complaint evaluations and ensure compliance.
• Interface with Third Party Manufacturers and regulatory agencies.

Skills

Biomedical engineering degree

Experience in complaint handling

Knowledge of FDA regulations

Experience with SalesForce

Strong motivation

Exceptional time management

Good problem-solving skills

Solid communication skills

Sound technical writing skills

Ability to work independently

Education

4-year biomedical engineering degree

2-year biomedical engineering degree with relevant experience

Tools

SalesForce

Job description

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.

Skills needed to be successful

• 4-year biomedical engineering degree; OR 2-year biomedical engineering degree and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Experience in complaint handling or quality engineering preferred (school projects and internships considered)
• 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.