Manager, Surgery Quality Systems

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

People Leader

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson Surgery Quality Systems is recruiting for a Manager, Surgery Quality Systems, located in Raritan, NJ; Cincinnati, OH or Irvine, CA.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Manager, Surgery Quality Systems leads and oversees the Ethicon Quality System, ensuring the effective management of quality system processes, performance metrics, failure investigations, and continuous improvement initiatives. This role drives data-informed decision making, promotes quality system excellence through organizational coaching and guidance, and supports compliance and operational effectiveness across the franchise. The position partners with the MedTech Quality Business Enablement team and cross-functional stakeholders throughout Ethicon to harmonize, integrate, and optimize Quality System processes, providing leadership and direction to enable consistent and effective execution.

Key Responsibilities:

• Manages the business execution of assigned Quality Systems processes in Ethicon including (but not limited to): CAPA, NC, DRB, QSMR, Quality Planning, and Quality Manuals.
• Supports complex investigations by coordinating technical and cross-functional teams to ensure robust experimental design, effective data analysis, and the timely identification, implementation, verification, validation, and closure of CAPA and Nonconformance activities
• Partners with J&J Sector and Enterprise teams, manufacturing sites, and franchise locations to support Quality Systems process execution and project initiatives.
• Monitors related Surgery business metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness. Monitor and drive Quality KPI performance to ensure sustainable compliance and operational excellence.
• Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
• Provides guidance and coaching on Quality Management System processes, and to Ethicon sites as needed.
• Leads activities in the initiation, investigation, evaluation, implementation of actions and approvals of nonconformances and corrective/preventive actions.
• Lead/host Quality Forums as applicable; Track action items for DRB/QSMR processes for Ethicon sites.
• Provides Internal/External audit support, acts as Subject Matter Expert as needed and supports the adjustment of the processes in response to compliance trends or actions.
• Provides guidance and support for Quality Management System processes to align with applicable regulatory requirements.
• Partners with Quality MQSA team to support internal/external audits, and Quality System project activities.
• Has the necessary independence, authority, and responsibility to identify and document quality problems, initiate or recommend solutions, and support actions to prevent nonconformities or address quality issues in accordance with applicable procedures.
• Responsible for communicating business  related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• For those who supervise or manage a staff, they are responsible for ensuring that subordinates follow all company guidelines related to health, safety and environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Performs other duties assigned as needed

Qualifications

Education:

• Bachelor of Science, Bachelor of Arts or equivalent degree is required.

Experience and Skills:

Required:

• Six (6) years of experience in the Pharmaceutical, Medical Device, or Biologics industry with Quality Systems experience required; people leadership or project leadership experience preferred; or an equivalent combination of education and experience.
• Strong communication, human relations, problem solving and analytical skills
• Demonstrated skills in root cause analysis and failure investigation
• Experience in dealing with audits/ inspections with the FDA, other notified bodies or any other Health Authority

Preferred:

• Experience owning & executing Quality system processes strongly preferred
• Proven experience in successfully collaborating across functions and delivering business results
• Strong documentation skills and technical writing capability.
• Experience in supporting health authority and or Notified Body inspections.

Other:

• Ability to travel domestically up to 10% is required.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Collaboration, Compliance Management, Corrective and Preventive Action (CAPA), Data Quality, Data Savvy, Developing Others, Incident Management, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Team Management

 

 

The anticipated base pay range for this position is :

$102,000.00 - $177,100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits