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

We are searching for the best talent for a Staff Quality Systems Engineer to be in Grecia, Costa Rica.

Purpose:

Provide high performance quality engineering guidance and support for development, maintenance and enforcement of compliance with the company-wide quality management system. The Staff Quality Systems Engineer will collaborate closely with business partners to provide leadership 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 Staff Quality Systems Engineer 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:

• Required Minimum Education: Bachelor’s Degree or Equivalent (preferably in Engineering, Math, Science, or Business)
• 7+ years Quality Systems, Quality Engineering, Quality Assurance, or other technical work experience;
• Minimum of 5+ years’ experience in an FDA regulated industry (medical device, pharmaceutical, etc.).

Skills:

• Working knowledge of 21 CFR Part 820, 21 CFR 806, ISO 13485, ISO 9001 and familiarity with ISO 14971;
• Broad-based 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;
• American Society for Quality (ASQ) credentials preferred
• Experience leading teams and with change management activities