Temp Quality & Regulatory Affairs Specialist ZFX M/F

We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions*. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future, and we hope you’ll consider being a part of it!

Job Mission:

To ensure the quality of the processes and products in accordance with current European Medical Device Regulation and ISO 13485 requirements and to maintain Quality Management System.

Main Functions:

• Document Control (eQMS)
• Prepare, review, approve, distribution and training on QMS documentation.
• Reporting and management of non-conformities and CAPAs.
• Participation on external audits by NBs and Inspections by CAs and performance of suppliers’ audits.
• Reporting and management of metrics (KPIs).
• Participate in the preparation of Management Review
• Supplier qualification and monitoring.
• Participation in manufacturing transfer projects and new product development
• Support on complaint handling.
• Review validation activities for supplier facilities, equipment and processes (IQ, OQ, PQ).
• Support on Change Management (Processes, product and QMS).
• Support to RA for the creation/update of technical documentation.

Profile:

• University degree in a Science related subject.
• 2 years’ experience in a similar position. Audit experience preferred.
• MS Office.
• Attention to detail.
• Communications and organizational skills.
• Initiative and flexibility.
• Mandatory knowledge of ISO 13485: 2016.
• Fluent English/Spanish (German is a plus).

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age or sexual identity.

• Requisition ID: 2959