Johnson & Johnson Careers
Staff Supplier Quality Engineer Auditor
Requisition ID: 1905770320W
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Johnson & Johnson Vision Care (Ireland) was established in 1995 in the National Technology Park close to the University of Limerick. The facility was originally fitted with six advanced production lines to manufacture one daily disposable contact lens for the European and Japanese markets. Since then we have expanded a number of times and now have over 40 production lines manufacturing one-day, fortnightly, monthly and colour contact lenses which are shipped worldwide.
Located in Limerick and produces the Acuvue range of contact lenses which is the leading contact lens product in the world. Our Limerick site uses the most advanced technology in the industry and we now employ over 1000 people directly. Using our highly automated production process, we produce daily disposable contact lenses while utilizing state of the art technologies such as injection moulding, robotics, vision systems and sterilisation systems.
Each year, we have increased output because of the increase demand for our Acuvue lenses throughout the world Continued expansion of our product lines and extensive engineering and retrofit projects ensure that this growth is sustained well into the future.
- Assures that the supplier quality system audit function aligns with QSR/GMP, ISO and other regulatory requirements.
- Performs audits of suppliers for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures.
- Performs supplier re‑audits of deficient matters and corrective actions, as needed and required.
- Can serve as lead auditor, leading a team of auditors, technical authorities, auditors-in-training and/or volunteer auditors. Provides direction and mentorship to auditors in training and/or volunteer auditors.
- Documents supplier audit results in written audit reports that are distributed and reviewed by appropriate management.
- Timely and accurately issues and maintain files associated with supplier audits, re‑audits and corrective action responses, and performs updates in the applicable audit tracking systems.
- Monitors the effectiveness of supplier corrective action responses.
- Collects and reviews supplier audit metrics and communicates to site and worldwide management. Generates data for management reviews.
- University Degree in a related science or engineering field of study; and 6 or more years of related experience and/or training; or Upper level University Degree with 4 or more years; or equivalent combination of education and experience.
Experience and Skills:
- Validated ability to conduct and handle audits.
- Computer Systems Validation experience preferred.
- Knowledge taking care of the Worldwide Health Authorities inspections.
- Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications.
- Good written and oral English communication skills.
- Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents.
- Strong understanding in FDA CFR Part 820, Part 11, ISO 130485 and/or other applicable laws. Strong knowledge of quality and compliance in a regulated GxP/QMS environment.
- Ability to select, manage and direct a team during an audit.
- Ability to effectively present information to top management, public groups, and/or boards of directors.
- Ability to respond to common inquiries, regulatory agencies, or members of the business community.
- Ability to take in the vital points of the audit and make big picture decisions and observations.
- Statistical skills and manufacturing process understanding.
- Ability to direct a team through a root cause analysis problem.
- Ability to stand firm while being open to new approaches. Engages in constructive conflict.
- High tolerance for ambiguity in a complex environment. Ability to solve practical problems and take care of a variety of concrete variables in situations where only limited standardization exists.
- Ability to build partnerships both internally and externally. Ability to effectively work with governmental and independent auditors.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson & Johnson Vision Care (Ireland) Limited (8182)