Quality Systems Manager

Nextern•Maple Grove, MN

5d•$120,000 - $140,000

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 is also responsible for the selection, implementation, administration, and monitoring of the Quality Management System, ensuring continual compliance of the organization. The role owns the audit, certification, and relationship maintenance of the company’s notified body and regulatory agency registration processes and coordinates functional leadership to properly resource and prioritize Quality initiatives.

Requirements

Bachelor’s degree or higher in business or STEM discipline from an accredited university, plus 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 it’s notified bodies
Performs other related duties as assigned by management.