Sr. Specialist, Quality (MDR)
In this role, you will be involved in global quality activities providing support to Medical Device sites quality leaders related to the Medical Device Regulation (MDR) 2017/745, such as quality agreements alignment and communication with customers, Medical Device contract reviews, Economic Operators and more.
location: Scottsdale, Arizona
job type: Temporary
salary: $50 - 55 per hour
work hours: 9 to 5
- Leading the MDR 2017/745 efforts together with the Medical Device sites quality leaders
- Responsible to identify each site's Economic Operators (Importer/distributor) and customers along with the applicable EU distribution zone and SKU
- Ensure that there are quality agreements between the sites and the applicable Economic Operator- Importer/distributor agreement to ensure that these agreements are aligned with the EU regulatory requirements.
- Ensure that there are quality Agreements between the sites and the applicable customers and ensure that these agreements are aligned with the EU regulatory requirements
- Communicate and coordinate quality agreements with customers/Economic Operators and work together with the sites quality leaders and Legal to ensure the agreements are signed
- Ensure (and update, when required) that all quality agreements are up to date with the state-of-the-art EU regulatory requirements along with references to the applicable SKU and EU distribution zones related to the relevant customer/ Economic Operator
- Create, maintain and control a list with all the customer/Economic Operator and their applicable references the purchased SKU and its distribution zones in EU
- Review each site's customer/ economic operator contract review (purchase order) to identify the link to the applicable quality agreements (including applicable distribution zones in EU and SKU)
- B.Sc./ BA in Science. Chemistry/ Biology/ Eng.
- At least 4 years working in quality system at Medical Device industry
- Experience with Quality agreements
- Experience with Project Management Tools, Quality Risk Management, and Six Sigma problem solving tools
- Courses on topics related to quality system in the medical device, regulatory requirements (specific to EU requirements)
- Experience with SAP, and Sharepoint a plus.
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.