Quality Assurance Specialist

hace 1 semana

Oaxaca, Oaxaca, México Johnson & Johnson Sa De Cv A tiempo completo

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Johnson & Johnson Sa De Cv. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.

Key Responsibilities:

  • Assist in the development of effective quality control and associated risk management plans.
  • Write process and product validation protocols and reports, equipment qualifications, engineering change orders.
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
  • Help to ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing.
  • Provide support in quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.
  • Assist in planning necessary to ensure effective product acceptance, including inspection instructions, equipment and gage requirements, and sampling plans.
  • Support vendor audits as technical lead as needed and support Supplier Quality as Franchise Quality representative as appropriate.
  • Support NC, CAPA, Internal Audit, Training and QS activities as needed and ensures compliance to all applicable due dates.
  • Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
  • Assist in complaint analysis as appropriate.
  • Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.

Requirements:

  • Under general supervision, participate in new and sustaining product/process teams to develop quality-engineered systems and products.
  • Lead and support design verification tests, process validations, quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards.
  • Support quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product.

Working at Johnson & Johnson Sa De Cv:

We are a global healthcare leader dedicated to transforming the lives of people around the world. Our company is built on a foundation of innovation, quality, and a commitment to making a difference in the lives of our customers and employees.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A comprehensive benefits package.
  • A competitive salary and bonus structure.

Language: English (en-US)

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