Quality Control Engineer

ENOVIS México, S.A. de C.V.; Baja California; Presencial; MXN 30,000 - 60,000; Jornada completa

Descripción de la vacante

An established industry player is seeking a dedicated Quality Engineer to enhance product quality and drive continuous improvement. In this pivotal role, you will implement quality planning, oversee quality control processes, and lead investigations into product complaints. Your expertise will be crucial in developing quality plans, conducting audits, and ensuring compliance with industry standards. If you have a strong engineering background and a passion for quality assurance in the medical field, this position offers an exciting opportunity to make a significant impact in a dynamic environment.

Formación

• Over 3 years of experience in a quality role, preferably in the medical industry.
• Intermediate English proficiency for conversations and presentations.

Responsabilidades

• Create quality plans with acceptance criteria for inspection.
• Supervise and analyze CPMs of products for trend analysis.
• Develop action plans to address major complaints.

Conocimientos

Problem-solving tools (RCCM, DMAIC, PFMEA)

Communication skills

Statistical methods

Customer-focused mindset

Educación

Professional engineering degree

Herramientas

MS Office

Minitab

Agile

Oracle systems

Descripción del empleo

Summary:

Accountable for implementing quality planning in one product area, aiming to continuously improve the site's quality performance. Responsible for quality control of products and processes. Conducts root cause investigations for top complaints, prioritizes failures, and defines relevant activities. Leads a PQ Team to hold recurring cross-functional meetings to identify barriers, trends, and opportunities.

Responsibilities:

1. Create quality plans with acceptance criteria for inspection, ensuring compliance with product-specific requirements.
2. Supervise and analyze CPMs of products to generate trend and Pareto charts.
3. Develop and coordinate action plans to address major complaints.
4. Review and approve validation protocols (IQ, OQ, PQ).
5. Act as the main partner in NPI processes (product transfer, CAPA administration).
6. Follow up on NCMR processes.
7. Conduct test validation on products.
8. Interpret drawings for specifications and tolerances.
9. Develop internal process audits.
10. Prepare PQT presentations and monitor KPIs.
11. Maintain high communication skills across all company levels.
12. Apply problem-solving tools (RCCM, statistical methods, DMAIC, Cpk, GR&R, PFMEA, 8D’s, etc.) to resolve issues.

Qualifications:

• Professional engineering degree.
• Over 3 years of experience in a quality role or similar, preferably in the medical industry.
• Intermediate English proficiency (capable of maintaining conversations and delivering presentations).
• Proficiency in MS Office, Minitab, Agile, Oracle systems.
• Basic knowledge of QA QSRs: ISO 13485-2016, CFR part 820, Risk Assessment, FDA Class I & II.
• Strong communication and negotiation skills.
• Customer-focused mindset with quick response capabilities.
• Knowledge of problem-solving tools and techniques.

Kindly upload your resume in English.