Senior Quality Systems Engineer

hace 2 semanas

Juárez, Chihuahua, México Johnson & Johnson A tiempo completo
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress.

That's why for more than 135 years, we have aimed to keep people well at every age and every stage of life.

Today, as the world's largest and most broadly based healthcare company, we are committed to using our reach and size for good.

We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere.

Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.


Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

We are searching for the best talent for SENIOR QUALITY SYSTEMS ENGINNER to be in Ciudad Juarez Mx, Cornelia GA, Raritan NJ, Cincinnati OH.**
Job Summary:The HQ CAPA QE supports the CAPA process as a CAPA site lead through supporting data analysis, assurance of robust CAPA failure investigation and content, supporting the CAPA Complaint Councils, monitoring of CAPA process metrics and serving as a coach and advocate for the CAPA process, while constantly seeking continuous improvement opportunities. The CAPA QE must also collaborate across the Ethicon Franchise to support the harmonization and integration of an optimized Ethicon CAPA process.

Duties & Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

  • Provides training regarding Quality Management System Elements (including, but not limited to CAPA, NC, DRB, Management Review, Quality Planning, Quality Manuals & Metrics) to representatives from other functional areas.
  • Facilitates or supports meetings (including, but not limited to CAPA, NC, DRB, Management Review, Quality Planning, Quality Manuals & Metrics)
  • Monitors and reports Quality Management System metrics.
  • Works on complex investigations and coordinates technical teams and leads cross functional teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, Non Conformance, and subsequent closure of investigations.
  • Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
  • Supports, participates, and leads in crossfunctional projects when assigned/appropriate.
  • Provides audit support for 3rd Party Inspections (e.g. Registrar, Notified Body, FDA, or customer audits).
  • Completes assessments for internal and external standards and regulations across Ethicon sites.
  • Processes document changes in applicable document management systems as needed including maintenance Franchise Quality Manuals and Quality Planning procedures.
  • Provide leadership on optimization and harmonization Quality projects across Ethicon.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Performs other duties assigned as needed.

Qualifications:

Experience and Education:

  • ABS degree in Engineering, Sciences, or Business Analysis is required.
  • Experience working in an FDA regulated environment is required.
  • Minimum of 23 years of experience working in an Operations, Manufacturing, Quality and/or Engineering role is required.
  • Strong communication, human relation, problem solving and analytical skills are all required.
  • Demonstrated skills in root cause analysis and failure investigation are required.
  • Experience in dealing with audits/ inspections with the FDA, other notified bodies or any other Health Authority.
  • Demonstrated Project Management skills with a strong results orientation.
  • Ability to communicate effectively with all levels of management and functions is required.
  • Strong in ability to build collaboration, partnership and teamwork across local and global organizations.
  • Demonstrated proficiency in problem solving skill sets and good analytical skills.
  • Demonstrated leadership skills without direct authority responsibility.
  • Demonstrated effectiveness as a team member and a team leader.
  • Adaptability for travel, both domestic and international (~10%)

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