- Carry out internal audits of the Quality System and participate in external audits.
- Support the validation activities of facilities, equipment, processes and computer systems as established in the internal procedures of the Quality System.
- Manage and review the control of product, process, and system changes from the perspective of Quality Assurance and carry out the actions derived from them.
- Participate in production transfer projects (Transfer in Transfer out).
- Make modifications and updates to documents as a result of the implementation of corporate procedures or other changes.
- Evaluate the conformity of spine products.
- Carry out the investigation of product when requested.
- Participate in projects for the industrialization of products and processes.
- Participate or Lead OPPs (Operating Project Plan) and improvement projects.
- Manage product and process non conformities according to internal procedures.
- Management of measurement and control equipment out of specifications according to internal procedures.
- Generate Control Plans and Guidelines for the different products and processes.
- Select appropriate measuring equipment to carry out the inspection of the manufactured product.
- Write and execute TMVs (Test Method Validation).
- Participate in the creation/management of Temporary Authorizations (TAs) or Memo's to File (MTFs), according to internal procedures.
- Prepare monthly indicators related to Quality Assurance activities.
- Manage deviations of manufactured products.
- Bachelor's degree (Supply Chain, Industrial Engineering or related field).
- Be in possession of a university degree in Engineering or similar.
- It is desirable to have at least 3 years of experience in a productive and multinational environment.
- Possess a high level of English, both spoken and written.
- It is essential to have knowledge in the use of office tools, especially Excel, as well as data analytics (Power BI).
- Knowledge of statistics associated with process control and sampling plans.
- It is desirable to have knowledge about the operation of a Quality System and the international regulations applicable to the business sector, such as ISO 9001/13485 or 21 CFR 820 regulations.
- Competitive compensation package
- Temporary contract
- Meal alowance
- Partially remote work option available
- Private life, health and dental insurance
- Learning & development program
- Requisition ID:
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Quality Engineer M - Paterna, España - ZimVie US Corp LLC
Descripción
We areZimVie, 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 forZimVie — we hope you'll consider being a part of it
About the role:
Guarantee quality in both the process and the finished product, as well as compliance with the quality standards established by the organization.
What you'll be doing:
What you'll need:
What we offer:
Working in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset.
Our culture empowers us to bring our whole selves to work each day, so we can be at our best when serving our customers, patients, and colleagues.
ZimVie offers you a challenging position with good career prospects in an international medical device business and following benefits:Apply online enclosing your cover letter, CV and references via our homepage
. We look forward to receiving your application
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.