TRS Consulting & Executive Search is partnering with a medical device company in their search for a Quality Systems Specialist located in the Minneapolis area.
The Quality Systems Specialist manages Complaints, CAPAs, and Nonconforming Material processes. The Quality Systems Specialist (QSS) works cross functionally with the Quality, Engineering, and Manufacturing teams to ensure complaints, CAPAs, and Nonconforming Material reports are documented appropriately and are completed within the expected timeframes. The QSS will be responsible for investigating complaints and responding to customers, as appropriate. The QSS will also monitor KPIs for the processes listed. The QSS will perform final batch record review and product release. Other Quality duties as assigned.
Job Duties and Responsibilities
Follow all regulations, standards, procedures and work instructions defined in the Quality System Manual
Sound knowledge of complaint handling requirements, including US, EU, Canadian, Australian, and Japanese reportability requirements
Ability to host effective meetings for Material Review Board, CAPAs, etc.
Review batch records and release product
Perform other duties as assigned by supervisor or manager
Education and Experience Required
Bachelor's Degree required in a Technical or Scientific discipline
Minimum 3 years of experience in a medical device environment
Complaint handling experience
Software proficiency: Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Strong background in FDA 21 CFR 820 Regulations, ISO 13485
Possess excellent verbal and written communication skills in English. Ability to read, write and speak English in order to comprehend and execute internal Procedures, Drawings, Manufacturing Work Instructions (MWI), etc.
Attention to details and excellent organization skills
CAPA and Nonconforming Material handling experience
Submit resumes to firstname.lastname@example.org
TRS Consulting is a division of THE RIGHT STAFF. We are a multi-specialty retained executive search firm and align well-qualified candidates to successful companies. Our success is achieved through analyzing a company's culture, corporate strategies, and future growth, and then fit these to a candidate's skills, professional background, and life experiences. For more information about our services, visit www.trscon.com.
No third-party vendor contacts, please.