Junior Product Complaints Engineer

About the role

Millyard Advanced Technologies is seeking a Junior Product Complaints Engineer to join our dynamic team. The ideal candidate will have a strong foundation in biomedical engineering, with or without relevant experience, and a passion for ensuring patient safety.

Responsibilities

• Review and evaluate product complaints related to potential medical device issues.
• Ensure that complaint documentation adheres to Good Documentation Practices and meets Quality Management System (QMS) requirements.
• Identify and report medical device issues to regulatory agencies as necessary.
• Interact with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies.
• Participate in audits and Corrective and Preventative Action (CAPA) investigations related to complaint handling.
• Collaborate with the forensic investigation team to align product investigations with complaint handling.
• Develop and maintain product training aids.
• Contribute to process improvement initiatives by generating reports.
• Communicate effectively with co-workers, customers, contractors, and vendors.
• Act as a subject matter expert on complaint handling processes.
• Perform other related duties as assigned under management supervision.

Requirements

• A 4-year biomedical engineering degree; OR a 2-year biomedical engineering degree and 2+ years of relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Experience in complaint handling or quality engineering is 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 complete tasks independently and contribute to 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 independently and collaboratively in a fast-paced, changing environment.

Qualifications

• Must be able to pass a background check.
• Must be legally authorized to work in the United States.

Skills

• Strong analytical and problem-solving skills.
• Excellent interpersonal and communication skills.
• Proficient in Microsoft Office Suite.
• Experience with medical device software and systems.
• Ability to work in a fast-paced, dynamic environment.

Benefits

Millyard Advanced Technologies offers a competitive benefits package including:

• Health insurance
• Retirement savings plan
• Flexible work schedule
• Professional development opportunities

Pay

$60,000 - $70,000 annually

Schedule

Full-time, Monday through Friday, 8:00 AM - 5:00 PM

About Millyard Advanced Technologies

Located in the heart of the Regen Valley in Manchester, NH, Millyard Advanced Technologies aims to positively influence the healthcare landscape. Established in 2019, we are proud to partner with industry leaders such as DEKA Research & Development.

About DEKA

DEKA Research & Development, located in the historic Amoskeag Millyard, is dedicated to making a difference through innovative engineering, design, and manufacturing. Our team works tirelessly to bring life-changing products to market and welcomes new ideas and collaborations.

Learn more about us at millyardadvanced.com.