Quality Engineer

hace 1 semana

Paterna, España ZimVie A tiempo completo

Welcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients. Our company is founded on a legacy of established brands, medical experts and over $1B in annual revenue. We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery and bone growth stimulation. Our seasoned leadership and dedicated global team of more than 2,500 is focused on shaping an exciting future for ZimVie — we hope you’ll consider being a part of it

**Job Summary**:
Quality Engineer mission is to guarantee quality in both the process and finished manufactured products, as well as ensure compliance with our internal quality standards.

**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.
- Process, investigate and issue product claim reports. Participate in the accomplishment of Health Hazard Evaluations and Health Hazard Evaluation Determinations.
- 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 PFMCAs investigations (Process Failure Mode Effects and Criticality 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**:

- 2-3 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 and SAP modules.
- Excellent planning, detail-oriented, organization and prioritization.
- Ability to take 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.

**Our offer**:
ZimVie offers you a challenging position with good career prospects in a fast-growing international business. We offer a competitive remuneration package.
- Competitive salary
- Flexible working arrangements
- Ticket Restaurant
- Private life & health insurance
- Dinning and leisure area
- Well-being activities and other benefits

**Contact**:
ZimVie Dental Valencia

C/ Islas Baleares, 50 Pol. Ind. Fuente del Jarro, 46988 Paterna, Valencia, Spain

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. ZimVie generally does not sponsor applicant work visas for this position.

Requisition ID: 999

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