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 Assurance
Job Category:
Professional
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 Electrophysiology
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
As Johnson & Johnson MedTech Electrophysiology, we have one goal – to ensure those with atrial fibrillation can live the lives they want. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrythmia treatment. Our suite of tools means electrophysiologists are empowered to personalize their approaches for patients with effective and reproducible workflows. Together, we’re changing what it means to be diagnosed with atrial fibrillation or other cardiac arrhythmias.
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 Manager
Purpose:
Plans, coordinates, and directs the quality assurance programs designed to ensure continuous production consistent with the established standards through the following responsibilities, either personally or through his/her subordinates. Directly supervises Quality Engineers (different levels/pay grades), Quality Team Leaders, Quality Supervisors, Quality Technicians and/or non-exempts associates in day-to-day activities supporting manufacturing lines, operator certification program, in-process and finished goods inspections; all in accordance with applicable regulations. Provide support and expertise on problem solving, process improvements and in the usage of quality tools.
You will be responsible for:
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Leads or support quality improvement initiatives, such as the characterization of processes and products that leads to continuous improvements / cost.
- Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
- Benchmarking in order to develop more effective methods to improve quality.
- Establishes and formulates the quality metrics to maintain the quality assurance objectives and alignment with the objectives of the plant.
- Supports the development of quality engineering and the compliance with the quality with the adequate abilities for the introduction of new products and product life cycle management of stabilized products.
- Promotes and supports the implementation of quality, product and process improvement projects.
- Revises and approves Change Request/Change Notices within the PLM system.
- Evaluation, monitoring and analysis of the quality costs in order to maintain a quality system according to the medical industry standards.
- Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within established timelines and budgets.
- Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.
Product Quality, Control and Disposition and Performance Standards:
- Directs and attends Revision meetings of NCs as a member of MRB.
- Revises and approves the investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints for high risk complaints or as applicable, and escalation of quality problems when applies.
- Responsible and owner of the identification of material, material segregation, classification of the types of defects, including the successful application of these techniques in the day-to-day in manufacturing.
- Provides direction and assigns resources for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level.
Compliance / Regulatory:
- Revises / analyzes if the current products and processes (including performed actions or decisions) comply with the regulations, such as the QSRs, ISO 13485, etc.
- Leads the preparations activities for regulatory agencies audits, including the active participation as “SME” or “Escort” (for example: FDA, JJRC, BSI, etc.).
- Revises and approves the answers to internal and external audit observations to ensure compliance with the internal procedures and applicable regulations.
- Establishes and properly maintains the required documentation of quality assurance activities and/or quality systems.
- Ensures the performance of periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the results of the audits of the area to ensure that the corrective and preventive actions are adequate.
Finance:
- Defines, monitors, and administers the central budget of the department.
- Approves purchase orders and expense reports submitted by direct reports.
Product Grading / Process:
- Revises and approves process validation strategies (Validation Plans).
- Ensures the realization of periodical maintenance and revision of the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.
- Approves the revision and maintenance of PFMEAs, Quality control Plans, Process Instructions and additional manufacturing documents.
- Provides support to the development and proper implementation of process monitoring and control methods consistent with the process/product risk level.
- Promotes the use of innovative tools for the timely detection and mitigation of risks.
- Determines the effectiveness of these techniques in the improvements previously implemented.
- Responsible and owner of the risk assessment evaluation including the realization, documentation, revision, maintenance of current risk and documentation of the risk assessment such FMEA of the process given to changes in the product/process.
Strategy:
- Collaborates with the quality leaders to identify the required quality engineering skills and competences that allow the execution of the strategic vision.
- Performs strategic planning with the site leaders and with the product engineering team.
- Works in team with other functions to establish the priorities of the business and assignment of resources.
People:
- Provides supervision, mentoring, coaching, performance revision, development plans and planning of the succession for others (when applies).
- Responsible for communicating business-related issues or opportunities to next management level.
- For those who supervise or manage a staff, 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 o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed.
The following must be included for all positions:
- Responsible for communicating business-related issues or opportunities to next management level.
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, 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.
- 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:
- University bachelor’s degree in science, BS in Engineering preferred. Master Degree Preferred.
- 6- 8 years of related experience in a regulated environment.
- 3+ years of supervisory experience.
- Experience in the Medical Device industry or medical field.
- Certifications such as CQA, CQE, CQM (preferably), CBA, MBB, BB is a plus, or ISO Certified Lead Auditor preferred.
- Advanced computer skills and use of software application(s).
- Fully Bilingual (Spanish & English).
- Strong technical writing skills are required.
- Leadership and management skills, including active involvement in problem solving and resolution of conflicts.
- Interpretation and application of QSR and ISO Standards.
- Excellent communication and interpersonal relation skills, with proven ability to effectively deal and negotiate with representatives of various government agencies and auditing agencies.
- Statistical and analytical problem-solving knowledge.
#LI-Onsite
Required Skills:
Preferred Skills:
Business Alignment, Coaching, Collaboration, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility