Quality Systems Supervisor

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:

Grecia, Costa Rica

Job Description:

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

About Cardiovascular

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

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

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

We are searching for the best talent for Quality Systems Supervisor.

Purpose:

Provide high performance quality engineering guidance and support for development, maintenance and enforcement of compliance with the company-wide quality management system. The Quality Systems Supervisor will collaborate closely with business partners to provide guidance with regard to Quality System Standardization activities to ensure activities are compliant with franchise procedures, J&J Medical Devices shared procedures, J&J Enterprise Standards, external standards & regulations, and Quality System related training.

You will be responsible for:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:

• The Quality Systems Supervisor will serve as a Quality Systems subject matter expert, track and report action plan status/ completion as relates to quality systems improvement efforts. 
• As needed, assist with creation and modification of Quality System procedures, work instructions and related documentation.
• Monitors and reports Quality Management System metrics. 
• Works on complex investigations and coordinates technical teams and leads cross functional teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, Non-Conformance, and subsequent closure of investigations.
• Responsible for conducting training in Quality Systems Management principles to business partners
• Facilitates process of product issue assessment, quality review board preparation, and field action execution.
• Provides training regarding Quality Management System Elements to representatives from other functional areas. 
• Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives. 
• Supports, participates, and leads in cross-functional projects when assigned/appropriate.
• Facilitates technical innovations to enhance Quality Systems and support business goals.
• Provides back room support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits).
• Responsible for communicating business related issues or opportunities to next management level

• Maintains Franchise Quality Manuals
• Maintains Quality Planning procedure
• Serves as a SME on the Quality Planning process, assists Quality Plan authors with the process, and files Quality Plans
• Performs semi-annual Quality Planning Governance
• Processes document changes in applicable document management systems
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications / Requirements:

Experience and education

• Required Minimum Education: Bachelor’s Degree or Equivalent (preferably in Engineering, Math, Science, or Business)
• 2-4 years Quality Systems, Quality Engineering, Quality Assurance, or other technical work experience; 
• Minimum of 2 years’ experience in an FDA regulated industry (medical device, pharmaceutical, etc.).

Required knowledge, skills, abilities, certifications/licenses and affiliations

• Working knowledge of 21 CFR Part 820, 21 CFR 806, ISO 13485, ISO 9001 and familiarity with ISO 14971;
• Technical knowledge and experience to work effectively with others in diverse areas of business (Operations, Quality, R&D, R.A., Engineering). 
• Ability to effectively prioritize and manage multiple activities and responsibilities;
• Experience using MS Project, preferred
• Must have outstanding business and technical communication skills (verbal, written, presentation)
• Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.) preferred
• Proficiency with quality-related applications such as those for MiniTab, Statgraphics, QI Macros, etc; preferred.
• American Society for Quality (ASQ) credentials preferred
• Experience leading teams and with change management activities

#LI-Onsite 

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Collaborating, Communication, Compliance Management, Data Quality, Data Savvy, Developing Others, Document Management, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People