Manager Quality Systems Process

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Athens Georgia United States of America Bridgewater Massachusetts United States of America Bridgewater New Jersey United States of America Cincinnati Ohio United States of America Danvers Massachusetts United States of America Fremont California United States of America Irvine California United States of America Irving Texas United States of America Jacksonville Florida United States of America Markham Ontario Canada Memphis Tennessee United States of America Monument Colorado United States of America Morrisville North Carolina United States of America Palm Beach Gardens Florida United States of America Raritan New Jersey United States of America Raynham Massachusetts United States of America San Angelo Texas United States of America Toronto Ontario Canada Warsaw Indiana United States of America West Chester Pennsylvania United States of America

Job Description:

Johnson & Johnson MedTech is currently seeking aManager Quality Systems Processto be located at any of the following J&J MedTech sites inNorth America: Irving TX San Angelo TX San Antonio TX Warsaw IN Raritan NJ Bridgewater NJ Jacksonville FL Cincinnati OH Memphis TN Raynham MA Bridgewater MA Palm Beach Gardens FL Monument CO West Chester PA Athens GA Morrisville NC Freemont CA Irvine CA Danvers MA Markham ON or Toronto ON.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 Manager Quality Systems Process is responsible for providing a high-performance quality systems leadership guidance and support for shaping monitoring assessment and implementation of key Quality Systems processes across Johnson & Johnson MedTech to maintain continuous compliance with standards and regulations balancing and continuously improving customer experience within the Systems Applications.

Included in the scope of Quality Systems are the following core business processes: Corrective Action Preventative Action (CAPA) and Nonconformance (NC).

Key Responsibilities:

• Ownership of the MedTech Shared CAPA & NC process and procedure maintaining a state of global regulatory compliance assessing opportunities for advancement and providing management with timely and comprehensive quality data
• Leads the advancement of the CAPA & NC processes including assessment and incorporation of automation and digital technology into the process and electronic system
• Business owner of the electronic system to manage CAPA & NC
• Supports Acquisition and Divestiture activities for the MedTech CAPA & NC processes
• Coordinates the appropriate governance activities to assure adequate analyses risk assessment and corrective/preventive actions are taken to mitigate product and process risk
• Coordinates the community of practice activities to ensure consistent execution of CAPA & NC processes and lead optimization activities
• Identifies tracks and provides the link to business partners for system enhancements and changes
• Provides active link and partnership with J&J Sector and Enterprise partners as well as the manufacturing sites and franchise locations across MedTech
• Monitors related Global metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness
• Manage and maintain the training and qualification program for the CAPA and Nonconformance processes
• Supports in the initiation investigation evaluation implementation of actions and approvals of nonconformances and corrective/preventive actions as necessary
• Assures CAPA & NC processes are compliant with regulatory requirements. Supports audits and acts as Subject Matter Expert as needed and drives the response to audit findings for NC & CAPA

Qualifications

Education:

• Bachelor of Arts Bachelor of Science or equivalent degree in a Life Science Engineering or Physical Science is required

Experience and Skills:

Required:

• Minimum of six (6) years of experience in the Pharmaceutical Medical Device or Biologics industry
• Proven experience in successfully collaborating across functions and delivering business results
• Strong communication documentation skills and technical writing capability
• Experience in managing health authority and or Notified Body inspections

Preferred:

• Quality system experience (CAPA/NC) strongly preferred
• Digital acumen knowledge and experience (understanding of PowerApps PowerBI Qlik Generative AI Agentic AI)
• Experience in Software Development Lifecycle (SDLC) and Agile methodologies

Other:

• Black Belt/ Green Belt certification from a recognized program or PE leadership training from J&J is an asset
• Adaptability for travel both domestic and international (up to 10% travel) is required
• ASQ - Certified Quality Manager is an asset

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 and 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 please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$100000- $173500

Additional Description for Pay Transparency:

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Holiday pay including Floating Holidays up to 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. For additional general information on Company benefits please go to: The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.