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 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.
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.
Requirements
QUALIFICATIONS:
- 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 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
Salary Range for This Position: $120,000 - $140,000
Nextern 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.
Skills Required
- Bachelor's degree or higher in business or STEM discipline
- 7+ years of relevant experience in ISO 13485 and FDA GMP
- 2+ years of experience managing a team
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
