Job Summary

Maintain effective quality processes and systems to ensure compliance to applicable Quality System Regulations. Monitor existing processes through trending and identify and implement process improvements. Support the internal and external audit programs as required and provide GMP and quality system training and guidance for employees and project teams. 

General Functions

 Implement and maintain quality system processes in compliance with GMP/ISO quality standards and lead quality system process improvements projects. 

 Facilitate corporate audits and external agency audits including FDA and other certifying bodies, government agencies, alliance partners and consultants. Correspond with these agencies regarding compliance issues, including GMP and ISO/EN requirements as needed.

 Lead and participates in Internal Quality Audits and Supplier Audits to ensure compliance to quality system requirements and to identify appropriate CAPA activity 

 Manage complaint investigations and resolutions. 

 Maintain the complaint handling system and review trend analyses and initiate corrective actions as appropriate. 

 Maintain corrective action system and documentation. Lead implementation of corrective and preventive actions. 

 Develops and conducts quality compliance training. 

 Support existing products and participate on existing product improvement projects as needed. 

 

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA. 

Expected Areas of Competence (i.e. KSAs)

 Proficient knowledge of ISO 9001, ISO 13485, Medical Device Directive and FDA Quality Systems Regulations. Experience in implementing and maintaining comprehensive systems to support all applicable requirements. Strong written and verbal communication and interpersonal skills. Experienced in working with and leading cross-functional teams. Proficient personal computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, graphics, etc. 

Education RequirementsBachelors degree in related discipline or equivalent work experience. 

Skill RequirementsMinimum five years experience in quality systems. 

 

Licenses/CertificationsQuality Auditor certification preferred (ASQ CQA or ISO 9000 Lead Auditor). 

Travel RequirementsUp to 10% 

 Requirements: 


 Areas of InterestQA-Compliance 

 ExpertiseQuality Assurance-QA 

 EducationBachelors 

 JobTypeFull Time 

 LocaleMN-Minneapolis 

 Job Experience3 - 5 years 

 PercentTravel1-10% 

 Preferred LanguageEnglish