.We are ZimVie , a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients' smiles, function, and confidence.
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 for ZimVie — we hope you'll consider being a part of it!
Principal Duties and Responsibilities: As a Quality Engineer, your responsibilities will be: Support the validation activities related to facilities, equipment, processes and computer systems as established in the internal procedures of the Quality System.
Coordinate and conduct preventive and corrective actions (CAPAs), product controls, process and system changes (Engineering Change Request - ECRs and DCRs) from the perspective of Quality Assurance and carry out derived actions.
Participate in production transfer projects (Transfer-in Transfer-out).
Make modifications and updates to internal documents as a consequence of the implementation of global procedures and other changes.
Participate in projects for the industrialization for new products and processes.
Take part in OPPs (Operating Project Plan) and Lean Manufacturing projects.
Conduct product non-conformities, process and quality system according to internal procedures.
Review product reprocesses (reworks and revisions).
Control equipment out of specifications, according to internal procedures.
Take part in the development of Quality Holds and product quarantines.
Generate control plans and guidelines for the different products and processes.
Write and run TMVs (Test Method Validations).
Manage temporary authorizations (TAs) and interim controls (ICs).
Collaborate in PFMEAs investigations (Process Failure Mode Effects and Analysis) and document DMRs (Device Master Records).
Analyze deviations of manufactured products.
Provide data for indicator reports for Quality Assurance activities.
Carry out internal audits of the Quality System and participate in external audits.
Education/Experience Requirements: The ideal candidate should meet the requirements for this role, and we expect from you: 2 years experience in a similar position, especially in manufacturing and a multinational environment.
BSc in Engineering (Industrial, Mechanical, Organizational); BSc in Biology, Health Science, Chemistry, or other related field.
Master's degree in Quality Management is an asset.
Proficiency in Spanish and English, both verbal and written.
Deep understanding of manufacturing processes and methods, quality management (ISO 9001) and Lean Manufacturing tools (Six Sigma, Kaizen, Kanban, 5S...).
Also, knowledge on statistics and specific medical regulations (ISO 13485, EU MDR 2017/745, 21 CFR FDA) is desirable