Quality Systems Manager

Nextern•Maple Grove, MN

About The Position

The Quality Systems Manager is responsible for the strategy, deployment, alignment, and maintenance of the Quality Management System for Nextern US sites. This role ensures continual compliance by overseeing the selection, implementation, administration, and monitoring of the Quality Management System. Additionally, the position owns the audit, certification, and relationship management with the company’s notified body and regulatory agencies, and coordinates with functional leadership to adequately resource and prioritize Quality initiatives.

Requirements

Bachelor’s degree or higher in business or STEM discipline from an accredited university
7+ years of relevant experience in ISO 13485 and FDA GMP
Experience with gap analysis and management of quality system standards changes
Experience in business case creation, selection, implementation, validation, and/or sustainment of electronic enterprise Quality Management System software programs
Experience aligning quality management systems across multiple facility locations, collaborating and building relationships with local site management representatives
Experience with the full range of ISO 13485 and FDA GMP, as it is associated to Class II and III medical device design, manufacturing, servicing, and distribution
Experience writing, changing, and auditing company/site level quality managing system procedures, compliant with ISO 13485 and FDA GMP
Experience managing and assuring the effectiveness of Management Review for US site
Experience managing and assuring the effectiveness of CAPA processes/systems for US site
Experience managing and assuring the effectiveness of global Document Control and Engineering Change Control processes
Experience managing and assuring the effectiveness of Complaint/Feedback processes
Experience managing and assuring the effectiveness of Quality System Audit (internal, customer, regulators) processes
2+ years of experience managing a team, formally or informally
Excellent Written & Oral Communication Skills
Experience with configuration of reports, security/access, data structuring, meta-data fields, and workflows in Product Lifecycle Management (PLM) systems, Propel PLM preferred
Excellent skills in standard computer-based software programs
Excellent skills in data analysis to report and present effectiveness of business processes

Nice To Haves

Experience in implementing foundational and expandable quality system strategies in a small-mid size company
Project management experience in transitioning to the ISO 13485:2016 standard
Project management experience in implementing an eQMS systems
Training/certification in Lean and Six Sigma
Training/certification in lead auditing ISO 13485 and FDA GMP systems

Responsibilities

Lead quality initiatives related to core QMS processes and systems
Define Quality performance metrics and implement systems to monitor performance
Facilitate Management Review and other periodic reviews, as necessary, for Nextern US site
Serve as liaison to PLM administrator to effectively implement automated controls aligned with Quality System requirements
Directly manage Quality Systems team, including engineers, specialists, and technicians
Establish and periodically review scalable and compliant Quality System processes including, but not limited to: CAPA, NCMR, Change and Document Control, Complaints, Training, and Audits
Establish alignment and accountability between Nextern US (corporate) and global Nextern sites for effective implementation, maintenance, and sustained compliance of the quality system
Directly manage the account relationships between Nextern and its notified bodies
Performs other related duties as assigned by management.