Quality Systems Manager

Duties and 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.

Supervisory Responsibilities

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

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.

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 Sigma
• Training/certification in lead auditing ISO 13485 and FDA GMP systems.

Benefits

• Nextern offers excellent benefits to fuel you in building a fulfilling life & career:
• Employer subsidized health insurance and dental insurance for employees
• Employer HSA contribution
• 401k plan with a company match
• 9 paid holidays (including your birthday!) + PTO and Personal days
• Gym membership subsidy
• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

Pay

Salary Range for This Position: $120,000 - $140,000