Acumed LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Job Scope

The Complaint Coordinator must demonstrate a strong work ethic, ability to work independently and have strong writing skills for completing investigative reports. Interfaces cross-functionally to ensure all product information and relevant information is included in the complaint investigation process. Responsible for complaint metrics and trending that is communicated to management for assessing the health of the QMS.

Responsibilities

• Receives, reviews, documents, evaluates, investigates, and coordinates responses on product complaints
• Works closely with Quality Engineering and Sustaining Engineering to complete investigation reports
• Effectively communicates across the organization on the complaints program status
• Evaluates complaints and completes complaint Medical Device Reporting (MDR) and Vigilance Reporting
• Document each complaint interactions accurately and thoroughly in the systems according to internal procedures
• Work cooperatively in a team environment to maintain cross-functional and cross-site processes and procedural consistency for quality system records
• Creation of monthly Quality Metrics using data throughout the QMS
• Works as a liaison for site audits and inspections
• Receives, reviews, documents, evaluates, investigates, and coordinates responses for recalled product or product enhancements.

Qualifications

• Exceptional attention to detail and strong organizational skills.
• Ability to adapt effectively within a continually changing and demanding environment.
• Demonstrate an understanding of the products and the processes involved.
• Experience working in an FDA-regulated environment
• Experience with document control, change control, internal or external audits, and/or complaint handling preferred
• Excellent problem-solving skills; demonstrated strength intact and diplomacy with internal and external collaborators
• Ability to work independently; exercise good judgment
• Strong experience with Microsoft Excel
• Experience in SAP preferred
• Excellent teamwork and collaboration skills
• Excellent written and communication skills

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [email protected], and please be sure to include the title and the location of the position for which you are applying.