Quality Systems Manager

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.

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.DUTIES AND

RESPONSIBILITIES:Lead quality initiatives related to core QMS processes and systemsDefine Quality performance metrics and implement systems to monitor performanceFacilitate Management Review and other periodic reviews, as necessary, for Nextern US siteServe as liaison to PLM administrator to effectively implement automated controls aligned with Quality System requirementsDirectly manage Quality Systems team, including engineers, specialists, and techniciansEstablish and periodically review scalable and compliant Quality System processes including, but not limited to: CAPA, NCMR, Change and Document Control, Complaints, Training, and AuditsEstablish alignment and accountability between Nextern US (corporate) and global Nextern sites for effective implementation, maintenance, and sustained compliance of the quality systemDirectly manage the account relationships between Nextern and it’s notified bodiesPerforms other related duties as assigned by management.SUPERVISORY

RESPONSIBILITIES:Directly supervises employees within the Quality Systems departments.Dotted-line supervision/mentoring of Quality Systems analysts at Nextern’s global facilities.Carries out supervisory duties in accordance with organizational policies and applicable laws.RequirementsQUALIFICATIONS: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.

Relevant experience aligns directly to the job specific responsibilities listed below:Experience with gap analysis and management of quality system standards changesExperience 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 siteExperience managing and assuring the effectiveness of CAPA processes/systems for US siteExperience managing and assuring the effectiveness of global Document Control and Engineering Change Control processes.Experience managing and assuring the effectiveness of Complaint/Feedback processesExperience managing and assuring the effectiveness of Quality System Audit (internal, customer, regulators) processes2+ years of experience managing a team, formally or informallyExcellent 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.Preferred

Qualifications: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 SigmaTraining/certification in lead auditing ISO 13485 and FDA GMP systems.BenefitsNextern offers excellent benefits to fuel you in building a fulfilling life & career:Employer subsidized health insurance and dental insurance for employeesEmployer HSA contribution401k plan with a company match9 paid holidays (including your birthday!) + PTO and Personal daysGym membership subsidyEmployee Short Term Disability, Long Term Disability, and AD&D Life InsuranceSalary Range for This Position: $120,000 - $140,000Nextern is an equal opportunity employer.

We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace.

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