Johnson & Johnson Careers
Quality Systems Specialist
Requisition ID: 1905710926W
Role: Quality Systems Specialist
Location: Johnson & Johnson Vision, Sunbury on Thames
Johnson & Johnson Vision, through its operating companies, is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, Johnson & Johnson Vision Care, Inc. has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses portfolio.
In 2017, with the addition of Abbott Medical Optics, Inc., the Johnson & Johnson Surgical Vision business, Johnson & Johnson invested further in eye health by expanding into cataract surgery, laser refractive surgery (LASIK) and consumer eye health. Serving more than 60 million patients a day across 103 countries, Johnson & Johnson Vision is committed to helping more people in more places improve or restore their sight.
We have an exciting opportunity for a Quality Engineer to join our team to be part of a new organization.
This role is ideal for someone who wants to progress their career collaborating across multiple functional areas and working closely with a highly dedicated and motivated team. You will be responsible for maintaining the Quality Management System and providing guidance to the J&J Vision EMEA region on quality system issues.
- Execute and document non-conformances, Corrective Action requests and Corrective and Preventative Actions and report on these metrics at Quality System management reviews
- Define and lead actions related to change requests
- Lead and document internal audits for compliance to regulations, agreements, standards and documented processes, of market Companies and Distribution Centres.
- Guide the development of and improve comprehensive measurement systems for quality performance.
- Ensure systems to measure, assess risk and escalate quality events. Manage quality events to identify, bracket, correct, control and prevent defects.
- Lead and document internal quality procedure change efforts.
- Provide guidance and leadership based on industry and process excellence standards at expert level, including good distribution practices (GDP), international organization for standardization (ISO) and country/governmental regulations (EU MDD/ MDR and ISO 13485 regulations/ standards will be the focus).
- Participate in quality system improvement initiatives.
- Act as CAPA Champion for the Region
- Maintain the training curricula for the region.
- Create Quality Management Reviews, in alignment with the business
- Support the coordination of field actions and escalations
Experience, Skills and Abilities
- You will have wide Quality Engineering experience and be able to work effectively across many different functions internally and externally which will ensure that we meet both the customer and the business needs.
- You will have a strong sense of personal responsibility and be able to work both as an individual leader and be a strong team player.
- Continuous improvement will be at the heart of your decision making, looking for areas in which we can create efficiencies through better working practices to deliver enhanced compliance.
- You'll conduct day-to-day and strategic activities in supplier lifecycle management, meaning you will be great at establishing clear expectations and collaborating with internal and external partners leading to consistent, reliable processes and services.
Skills and Abilities (Can Do Criteria):
- You will be degree qualified, preferably a science degree, with experience of working in a regulated environment.
- Demonstrable experience in Quality Assurance from within another function in the medical device, pharmaceutical or related industry experience.
- Exceptional communication skills to allow you to work effectively across various levels and teams
- A passion for continuous improvement
- Lead Auditor training (ISO13485) – Desirable but not essential
- It would also be preferred if you were knowledgeable in ISO and EU MDD/ MDR regulations and have experience of Good Manufacturing Practice (GMP).
To be a success in this role you will be proactive, independent and committed, with a can-do attitude which will enable you to build effective relationships and networks locally/regionally. You will be able to make complex issues clear and transparent and be a strong problem solver.
CLOSING DATE: Thursday 21st February 2019
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act
United Kingdom-England-Sunbury on Thames-
Johnson & Johnson Medical Ltd. - fka -Ethicon Ltd. (7355)