Quality Engineer

hace 1 día


Paterna, España ZimVie US Corp LLC A tiempo completo

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**:

- 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 on 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.
- Good computer skills, including proficiency with MS Office tools.
- Excellent planning, detail-oriented, organization and prioritization.
- Ability to make decisions, analysis and problem-solving.
- Ability to build strong relationships with other areas of the company and ability to influence others.
- Strong attention to details and multitasking.
- The position is requiered in Valencia, Spain.

**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:

- Competitive compensation package
- Permanent contract
- Meal alowance
- Private life, health and dental insurance
- Learning & development program

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: 2753


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