Junior Product Complaints Engineer

DEKA Research & Development • Manchester, NH

2d

About The Position

DEKA R&D, on behalf of Millyard Advanced Medical Products, is seeking a Junior Product Complaints Engineer to work in a medical device research and development environment. This high-visibility role has a direct impact on the Quality Management System and reports to the Product Complaints Manager.

The engineer reviews and evaluates complaints involving potential medical device issues, ensures complaint records meet documentation, quality-system, and regulatory requirements, and makes decisions about medical device reporting. The role works with external and internal stakeholders, supports audits and CAPA investigations, coordinates with forensic investigators, develops reports and product training aids, and serves as a subject matter expert in complaint handling. The engineer is expected to contribute independently, collaborate across teams, and perform other related duties under management supervision.

Requirements

• A four-year biomedical engineering degree, or a two-year biomedical engineering degree and at least two years of relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Strong motivation to complete individual tasks and help achieve team goals.
• Exceptional time management and ability to prioritize multiple projects while ensuring compliance with regulations and standard operating procedures.
• Good problem-solving and proficient computer skills.
• Solid written and verbal communication, organizational skills, and attention to detail.
• Sound technical writing skills.
• Ability to work independently and on cross-functional teams in a fast-paced, changing environment.

Nice To Haves

• Experience in complaint handling or quality engineering; school projects and internships are considered.
• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820, and 211).
• Experience with Salesforce.

Responsibilities

• Review complaints related to potential medical device issues.
• Perform product complaint evaluations with minimal direction, using experience and product knowledge.
• Ensure complaint documentation follows Good Documentation Practices, meets QMS requirements, and complies with FDA and 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 related to complaint handling.
• Work with the forensic investigation team to align product investigations related to complaints.
• Generate reports to identify areas for process improvement.
• Develop product training aids.
• Contribute independently and collaborate with 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level