Executive Quality Operations

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.
As pioneers in medical devices, we continually focus on elevating the standard of care—working to expand patient access, improve outcomes, reduce health system costs and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.

**SECTION 1: JOB SUMMARY**

Job purpose of Executive Quality Operations is to plan, coordinate and direct Quality operation designed to ensures continuous production of products consistent with established standards by performing the following duties and responsibilities.

**SECTION 2: 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:

- Ensure Product & Process Quality operations in compliance with applicable regulations and policies, including FDA, safety and environment and ensure that Good Manufacturing Practices (GMP) are followed on shop floor.
- Lead In-Process Quality Assurance process and activities as part of Quality Operations.
- Ready to work in Shifts (Ist, IInd & IIIrd) as per business requirement in manufacturing environment.
- Has Knowledge and experience of Change Control, Validation, Nonconformance, CAPA, PQR, QSMR & SAP system.
- Train and supervise the IPQA staff.
- Improve the efficiency of the IPQA using process excellence and lean principles.
- Communicate department objectives and metrics.
- Assure personnel are properly trained and developed for their function and future responsibilities.
- Communicate metrics and systems used to measure and guide improvements to product and quality system and customer satisfaction to quality operations staff.
- Ensure resolution of daily IPQA issues, inter and intra department.
- Provide inputs to IPQA reports, requirement and other information in response to requests for proposals, quotes and other business opportunities.
- Review of Sterilization records for autoclave and EO sterilization.
- Make recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production cost.
- Responsible for revision/creation of documents like SOP & QAP required for manufacturing the product.
- Ensure the correctness and availability of the artwork (Product Graphics) to enhance market acceptability.
- Ensure compliance to Quality System requirement.
- Utilize problem solving skills and statistical techniques to support product / processes control that are aligned with the overall quality and business vision.
- To represent Quality Operation function and provides technical support and information to production and Utilize cost control initiatives to reduce expenses.
- Responsible for managing overall site Quality Operation Program in compliance with all applicable regulations and policies, including FDA, safety and environmental.
- Responsible to formulate, coordinate and meet Quality operations objectives & strategy.

**Compliance & Training**
- Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notify any violation or deviation to the immediate supervisor or appropriate authority.
- Complies with all training requirements to perform duties of the job.
- Ensure adherence/compliance to Records Management policies and procedures, as applicable.

**Qualifications**:
**SECTION 3: EXPERIENCE AND EDUCATION**
- Graduate in Pharmaceutical Sciences / Postgraduate in Science / Bachelors in Engg. with minimum 4-6 years relevant experience in Quality Assurance / Quality Operations/Quality System function in Pharmaceutical/ Medical Device industry.
- Green belt certification in lean six sigma with demonstrated experience in quality projects is preferred.
- Experience of working in a regulated industry like Pharmaceutical / Medical Devices is highly desirable.
- Working knowledge of Laboratory Software’s is preferred. For example, LIMS system, ETQ NC, ETQ CAPA, Trackwise, etc.

**SECTIO