Complaint Coordinator

Marmon HoldingsHillsboro, OR
2d

About The Position

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.

Requirements

  • 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
  • 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
  • Excellent teamwork and collaboration skills
  • Excellent written and communication skills

Nice To Haves

  • Experience with document control, change control, internal or external audits, and/or complaint handling preferred
  • Experience in SAP preferred

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.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

No Education Listed

Number of Employees

5,001-10,000 employees

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