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Entry Level Complaint Handling Medical Device Jobs

Spectra force

Data Entry Associate

Collegeville, PA · On-site

$15.75 - $20.50/hr

... and medical device products, packaging, and labeling with emphasis on complaint handling requirements. *Experience with sterile and medical device product within a healthcare setting and/or ...

Jj

Senior Quality Investigation Engineer

Horsham, PA · On-site

$87K - $118K/yr

... and support complaint handling processes throughout the product lifecycle. Additional ... Medical Device Reporting requirements * Supporting complaint-related site escalations and ...

Collabera

Vigilance Specialists

Minneapolis, MN · On-site

Associate MDR/Vigilance Specialists are responsible for theintake, documentation, Medical Device ... Document required information in Global Complaint Handling (GCH). Assess complaint file for missing ...

Collabera

Complaint Investigations Tech

Alameda, CA

Must possess good laboratory practices, including handling of chemicals and biohazardous material ... Basic mathematical skills Qualifications Looking for candidates in Medical device industry ...

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Entry Level Complaint Handling Medical Device information

What are the key skills and qualifications needed to thrive as an Entry Level Complaint Handling Medical Device Specialist, and why are they important?

To thrive in this role, you need a background in life sciences or engineering, strong attention to detail, and familiarity with regulatory standards like FDA or ISO 13485. Proficiency with complaint management systems, database software, and document control tools is typically required. Excellent written communication, critical thinking, and teamwork skills help ensure accurate investigation and reporting of complaints. These abilities are vital to maintain product quality, ensure compliance, and safeguard patient safety in the medical device industry.

What are some common challenges faced in an entry-level complaint handling role in the medical device industry?

In an entry-level complaint handling role for medical devices, a common challenge is quickly understanding complex regulatory requirements and accurately documenting each complaint according to strict industry standards. You may also encounter difficulties when liaising between customers, quality assurance, and engineering teams to gather necessary information for investigations. Additionally, learning to prioritize cases based on risk, while maintaining attention to detail and clear communication, is essential for success. Support from more experienced colleagues and access to robust training materials can help you overcome these challenges as you develop your expertise.

What is the difference between Entry Level Complaint Handling Medical Device vs Entry Level Customer Support Medical Device?

AspectEntry Level Complaint Handling Medical DeviceEntry Level Customer Support Medical Device
CertificationsBasic medical device regulations, quality standardsCustomer service skills, product knowledge
Work EnvironmentQuality assurance departments, complaint review teamsCall centers, help desks, online support
Employer & Industry UsageMedical device manufacturers, healthcare companiesMedical device companies, healthcare providers

While both roles involve interaction with medical device users, Complaint Handling Medical Device focuses on investigating and resolving product complaints, ensuring compliance with regulations. Customer Support Medical Device emphasizes assisting customers with product inquiries and technical issues. The former requires knowledge of quality standards, while the latter centers on communication skills. Both roles are essential in maintaining customer satisfaction and product safety within the medical device industry.

What does an Entry Level Complaint Handling Medical Device professional do?

An Entry Level Complaint Handling Medical Device professional is responsible for receiving, documenting, and processing complaints related to medical devices. They ensure that all complaints are recorded accurately, investigate basic issues, and escalate complex cases to senior staff. Their work helps companies comply with regulatory requirements, maintain product quality, and protect patient safety. This role often involves communication with customers, regulatory agencies, and internal teams to resolve issues efficiently.
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Entry Level Complaint Handling Medical Device jobs near you
Infographic showing various Entry Level Complaint Handling Medical Device job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Product Complaints Engineer - Team Lead

DEKA

Manchester, NH • On-site

Full-time

Re-posted just now

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
  • Contract Manufacturer: Merrimack Manufacturing

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.

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