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:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Grecia, Costa RicaJob 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
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for.
Purpose:
Provide high performance quality system guidance and support for development, maintenance and enforcement of compliance of the company Quality Management System. The Quality Senior Analyst will collaborate closely with business partners to provide leadership regarding the Quality System Standardization activities ensuring the site is compliant with franchise procedures and external standards & regulations.
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:
- 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, modification and improvement of Quality System procedures, work instructions and related documentation.
- Drive robust quality and compliance execution in the business and drive successful Q&C scorecard metrics by working closely with key stakeholders in the business.
- 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.
- Oversee all Compliance activity within the facility in conjunction with the Regulatory Compliance and Quality Operations groups. Liaise with management at all levels of the business and produce metrics and present data on site performance at meetings such as the weekly and monthly management meetings
- Oversee the Customer Complaints system in conjunction with Complaints and Vigilance Manager, ensuring that timely closure is met whilst fully satisfying all Customer Complaint requirements.
- Ensure that the Quality System Review (QSR) continues to develop in terms of inputs and to ensure that any trends noted at this forum are challenged and acted upon
- 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.
- 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).
- Serves as a SME on the Quality Planning process, assists Quality Plan authors with the process, and files Quality Plans
- 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:
Experience and education
- Required Minimum Education: University Bachelor’s Degree or Equivalent (preferably in Engineering, Math, Science, or Business)
- 4-6 years’ experience in Quality Systems, Quality Engineering, Quality Assurance, or other technical work experience.
- Minimum of 4+ 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 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.
- 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 statistical applications such as those for Minitab.
- American Society for Quality (ASQ) credentials preferred
- Experience leading teams and with change management activities
- Bilingual (English and Spanish)
#LI-Onsite
Required Skills:
Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)Skills Required
- Bachelor's degree or equivalent, preferably in Engineering, Mathematics, Science, or Business
- 4-6 years of experience in Quality Systems, Quality Engineering, Quality Assurance, or other technical work
- At least 4 years of experience in an FDA-regulated industry, such as medical devices or pharmaceuticals
- Working knowledge of 21 CFR Part 820 and 21 CFR Part 806
- Familiarity with ISO 13485 and ISO 14971
- Broad technical knowledge across Operations, Quality, R&D, Regulatory Affairs, and Engineering
- Ability to prioritize and manage multiple activities and responsibilities
- Strong verbal, written, business, technical, and presentation communication skills
- Project Management Certification, such as PMI Certification or a Graduate Certificate in Program Management
- Proficiency with quality-related statistical applications such as Minitab
- American Society for Quality credentials
- Experience leading teams and managing change
- Bilingual English and Spanish language skills
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
