QUALITY OPERATIONS LEAD

Johnson & Johnson; Ciudad Juárez; Presencial; USD 60,000 - 100,000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Quality Operations Lead to join their innovative team in Ciudad Juárez. This role focuses on leading quality improvement initiatives, ensuring compliance with industry standards, and driving continuous improvement in processes and products. The ideal candidate will possess strong problem-solving abilities and excellent communication skills, with a solid background in engineering and quality assurance. Join a forward-thinking company dedicated to enhancing health through innovative solutions and make a significant impact on patient wellness.

Formación

• 8-10 years of experience in quality assurance or related field.
• Bachelor’s degree in Engineering or applicable sciences required.

Responsabilidades

• Lead quality improvement initiatives and analyze effectiveness of tools.
• Establish quality metrics and ensure compliance with standards.

Conocimientos

Problem-Solving

Communication Skills

Quality Improvement Techniques

Lean Techniques

Six Sigma

Educación

Bachelor’s Degree in Engineering

Master’s or Doctorate in Applicable Sciences

Herramientas

Quality Metrics Software

Statistical Analysis Software

Descripción del empleo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

MX301 – Circuito Interior Norte - BWI, MX905 Manuel Talamas Camandari 2849, Lote Bravo, Ciudad Juarez, Chihuahua

Job Description:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Quality Operations Lead to be in Juarez City.

You will be responsible for:

1. Leading or supporting quality improvement initiatives, such as process and product characterization that leads to continuous improvements and cost reduction.
2. Reviewing and analyzing the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and other improvement tools and programs.
3. Conducting benchmarking to develop more effective quality improvement methods.
4. Establishing and formulating quality metrics to maintain quality assurance objectives aligned with plant goals.
5. Supporting the development of quality engineering and ensuring compliance with quality standards for new product introduction and lifecycle management.
6. Promoting and supporting quality, product, and process improvement projects.
7. Reviewing and approving Engineering Change Orders (ECOs).
8. Evaluating, monitoring, and analyzing quality costs to maintain a compliant quality system according to medical industry standards.
9. Reviewing and analyzing product and process compliance with regulations such as QSRs, ISO 13485, etc.
10. Leading preparation activities for regulatory agency audits, including active participation as SME or Escort (e.g., FDA, JJRC, BSI).
11. Reviewing and approving responses to audit observations to ensure compliance with procedures and regulations.
12. Participating in Revision meetings of NCs as a member of MRB.
13. Reviewing and approving investigations, documentation, and actions related to non-conformities, CAPAs, customer complaints, and quality issues.
14. Managing material identification, segregation, defect classification, and applying these techniques in manufacturing.
15. Providing direction and resources for resolving complex manufacturing problems at local or franchise levels.

Qualifications / Requirements:

1. Bachelor’s degree, preferably in Mechanical, Electrical, Industrial Engineering, or applicable sciences.
2. Master’s or Doctorate in applicable sciences is preferable.
3. 8 to 10 years of relevant work experience or demonstrated performance.
4. Proficiency with computer packages.
5. Ability to effectively communicate and negotiate with government and auditing agencies.
6. Excellent spoken and written English communication skills.
7. Ability to actively involve in problem-solving and resolution.
8. Good judgment in problem-solving is highly desirable.
9. Certifications such as CQA, CQE, CQM (preferably), CBA, MBB, or BB are a plus.