Nextern

Nextern

Quality Systems Manager

Maple Grove, Minnesota, United States

Sponsorship not specified$120k-$140kDetected 65 days ago
Data AnalysisProduct ManagementProject ManagementAuditingProcess ImprovementGMPFDA RegulatoryMedical DevicesLeadershipCommunicationMentoring

About the role

  • SUMMARY: The Quality Systems Manager is responsible for strategy, deployment, alignment, and maintenance of the Quality Management System for Nextern US sites.
  • The role is also responsible for the selection, implementation, administration, and monitoring of the Quality Management System ensuring continual compliance of the organization.
  • SUPERVISORY RESPONSIBILITIES: Directly supervises employees within the Quality Systems departments.

Responsibilities

  • 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.

Requirements

  • Experience writing, changing, and auditing company/site level quality managing system procedures, compliant with ISO 13485 and FDA GMP.

Nice to have

  • 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.
  • 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 configuration of reports, security/access, data structuring, meta-data fields, and workflows in Product Lifecycle Management (PLM) systems, Propel PLM preferred.

Compensation

  • $120k-$140k

Benefits

  • Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Company info

  • 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.

Equal opportunity

  • $120,000 - $140,000 Nextern is an equal opportunity employer.
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