Johnson & Johnson Careers
Senior Quality Engineer - (Validation)
Requisition ID: 1905732465W
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
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.
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.
1. Job Purpose:
Short statement stating exact purpose of the role:
- Support the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations,
- Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions,
- Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements,
- Implement J&J policies and procedures.
Main areas of responsibility:
- Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
- Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
- Runs /Manages complaint investigation and resolution of same
- Designs and develops validation documentation to support business continuity, new process introductions
- Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
- All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
Qualifications / Requirements:
- A Bachelor’s degree from accredited college
- Minimum 3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry.
- Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
- Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
- Ability to demonstrate standards of leadership – Managing Complexity/Credo Values/Innovations/Customer focus.
- Team Player
- Good Influencing Skills
- Strong leadership, collaboration and influencing skills.
- Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO-13485) applicable to the manufacture of Class III medical devices to Global markets.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Johnson & Johnson Vision Care (Ireland) Limited (8182)