The Quality Compliance Coordinator (Quality) provides support for a number of key compliance related activities including REACH and RoHS compliance, quality system training coordination, execution and test administration. This role also supports document archival and off-site storage and handling customer complaints and information requests.
Scope of Responsibilities: REACH/RoHS Compliance
- In coordination with the Contract Administrator and Legal Assistant, obtain supplier component certifications for purchased components in support of product certifications for REACH and RoHS
- Maintain the component certifications database
- Maintain employee QMS training database for new and existing employees
- Identify employee training requirements, write training plans and schedule training
- Support development of online training quizzes to be administered to employees
- Maintain employee QMS training records
- Monitor progress of completion of required training
- Coordinate revisions to quality system documents from creation through to obsolescence
- Maintain off-site document storage and coordinate document archival of QMS records
- Support processing of NCRs through to completion
- Maintains and issues monthly quality metrics report
Customer Complaints Support
- Provide support of customer regulatory inquiries and complaints about company products
- Maintain customer change notifications
- Our company is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices, and employees of our company.
- Our objective is to maintain a Quality Management System in compliance with ISO 9001, ISO 13485, the US FDA Quality System Regulation as well as any additional regulatory requirements of the markets in which our products are sold.
- Employees of our company are instrumental to our compliance efforts and are required to understand and comply with the QMS.
Education and Professional Qualifications:
- Strong working knowledge of company products and processes
- Understanding of quality system requirements for documentation
Desired Characteristics/Additional Assets:
- Excellent verbal and written communication skills
- Must be able to effectively communicate with many levels of Engineering, Quality, Sales and Marketing, and Manufacturing
- Excellent attention to detail and organization skills
- Ability to work independently