Associate Quality Engineer M/F

Job description

We are ZimVie , a 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! ABOUT THE ROLE: Ensure quality in both the process and the finished product, as well as compliance with the quality standards established by the organization. MAIN RESPONSIBILITIES: Participate in both internal Quality System audits and external audits. Manage preventive and corrective actions (CAPAs). Provide support for the validation of facilities, equipment, processes, and IT systems in accordance with the Quality System’s internal procedures. Develop and execute Test Method Validations (TMVs) and Software Validations. Manage and review change control for products, processes, and systems from a Quality Assurance perspective and implement the resulting actions. Provide support in managing Health Hazard Evaluations (HHE) and Health Hazard Evaluation Determinations (HHED), product holds (internal/external), and product quarantines. Participate in production transfer projects (Transfer-in or Transfer-out). Provide support in investigating complaints regarding products manufactured at ZimVie Spain when requested by the Legal Manufacturer. DESIRABLE REQUIREMENTS: Have recently earned a university degree in Engineering (or similar) and have less than 2 years of work experience, or hold an Advanced Vocational Degree and have more than 1 year of experience at ZimVie performing duties similar to those of this position. Possess a sufficient level of English to be able to interact with both colleagues at the U.S. plant and external auditors. Have knowledge of office software, especially Excel, as well as data analytics (Power BI). Additionally, knowledge of ERP systems, particularly Oracle, is a plus. Basic knowledge of statistics related to process control and sampling plans. Knowledge of how a Quality Management System operates and of the international standards applicable to the company’s industry, such as ISO 9001/13485 or 21 CFR 820. 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, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws. ZimVie generally does not sponsor applicant work visas for this position. Requisition ID : 3644