Process Quality Leader

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong

We are searching for the best talent for Process Quality Leader to be in Ciudad Juarez Chih.

Purpose:
The Process Quality Lead position is established to enhance the Quality activities on the business unit, such as nonconformances, complaints, attend internal and external audits, audit observations resolution, quality indicators, escalation processes, CAPAs, DRB, PQSS and any quality issue affecting the business unit.

Promote Quality Culture in Operations and Lead & engage strategies for risk management

You will be responsible for:
Under general direction and in accordance with all applicable federal, state and local

laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Develop and supervise effective defect tracking mechanisms and coordinate improvement actions.
- Lead efforts and projects to improve quality performance for the Business Unit, including In-Process Reporting, Software Upgrades to systems, etc.
- Lead quality system improvements, which result from internal audits, QLT, and Quality Board Issues, as required.
- Responsible for the appropriate execution of Quality Assurance test methods and inspections procedures of raw material, work in progress and finished product for the Business Unit.
- Establish and maintain programs, procedures and controls ensuring that product and raw materials are manufactured and controlled as per established procedures, specifications, medical device regulations, sterilization guidelines, and ISO standards.
- Support cost savings opportunities that work toward achieving the objectives of the Business Unit.
- Responsible for ensuring compliance with procedures for all nonconforming product and raw materials applicable to the Business Unit.
- Support projects and new product introductions by establishing key checkpoints for new products and processes.
- Ensure compliance with company policies and procedures.
- Promote the use of quality metrics and performance data to drive improvements.
- Active participant in CAPA council boards (plant and franchise) and Management Review to identify and lead process improvements to reduce or eliminate complaints.
- Establish a process to assess the use of internal quality data as a predictor to reduce/eliminate product complaints.
- Work with Materials Planning and Manufacturing to facilitate testing and release of product.
- Review and participate in personnel development programs necessary to provide employee movement through prescribed promotional patterns.
- Evaluate and recommend staffing requirements to optimize the utilization of personnel to fulfill Business Unit objectives.
- Responsible for the coordination of Business Unit activities with QA partners for corrective and preventive actions.
- Acts as CAPA owner and coordinator as determined by the Business Unit Manager or Director.

**Qualifications**:
EXPERIENCE AND EDUCATION:

- Experience in Medical Device Industry preferred.
- A Minimum of BS in Engineering.
- CQE (ASQ) Certified, preferred.
- Certification in Lean Manufacturing or Six Sigma is preferre d
- 4-6 years related experience in a similar role
- Proven initiative, creativity, assertiveness, and leadership skills.
- Excellent interpersonal, influencing, communication, presentation, listening, and negotiation skills.
- Ability to set priorities and achieve objectives.
- Excellent analytical and statistical skills.
- Proven skills in root cause analysis, problem resolution and documentation practices