Staff Process Quality Lead

hace 3 semanas

Ciudad Juarez, México Johnson & Johnson A tiempo completo

At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity.

Diversity & 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 Next Move Could Mean Our Next Breakthrough.**Company: ETHICON ENDO**

**Searching the best talent for**: STAFF PROCESS QUALITY LEAD

**JOB SUMMARY**
- 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.

**DUTIES & RESPONSIBILITIES**

Responsibilities may include, but are not limited to:

- 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.
- Support efforts in the use of Process Excellence tools to enhance analytical thinking and problem-solving techniques.
- In depth knowledge and analysis of voice of the customer (product complaints) and lead process improvements in collaboration with Engineering and Manufacturing to reduce or eliminate Product Complaints.
- 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.
- Acts as Risk Escalation Owner to drive investigation and communication to Risk Management Board.
- In conjunction with QA partners, prepares presentations for QLT and QB meetings and represents the Business Unit in CAPA reviews.
- Track and monitor CAPA metrics for the Business Unit and drives actions for improvement.
- Lead improvements in quality performance metrics for the Business Unit such as responses to internal and external audits, NCR, QNC, compliance training, etc.
- Ensure compliance to the quality policy in all activities
- Promotes Quality Culture in Operations by facilitating trainings, quality talks and other engagement strategies.
- Support and promote the safety and industrial hygiene objectives of the site.

**Qualifications**:
**EXPERIENCE AND EDUCATION**
- requires 6-8 years related experience.
- Experience in Medical Device Industry preferred
- A Minimum of BS in Engineering
- CQE (ASQ) Certified, preferred
- Certification in Lean Manufacturing or Six Sigma is preferred.

**REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS**
- Proven initiative, creativity, assertiveness, and leadership skills.
- Must be able to work under pressure achieving consistently high results through individual and team efforts.
- Master’s Degree (prefer

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