Johnson & Johnson Careers
QUALITY SPECIALIST -Customer
Requisition ID: 1805689184W
Role: Quality Specialist- Customer x 3
Location: Cork, Ireland
Reports to: Manager Health Authority Reporting - EU MDR (currently hiring for this role)
DePuy Synthes Companies of Johnson & Johnson, is the largest, most comprehensive orthopaedic and neurological business in the world, built upon the strong legacies of two great companies. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials.
Our broad array of inspired, innovative and high-quality offerings advance the health and wellbeing of people around the world.
DePuy Synthes established its manufacturing facility in Cork in 1997 where it manufactures orthopaedic knees and hips, from this date the company has expanded to include a Global Supply Chain Operation in 2002 and more recently in 2008 DePuy established an Innovation Centre which was created to develop next generation orthopaedic products and processes for a global market. In 2014, DePuy Synthes in Cork won the Shingo prize for Operational Excellence.
As a Quality Specialist- Customer, your typical day may include:
• Submission of initial and final vigilance reports in accordance with MEDDEV 2.12-1 current revision.
• Co-ordinating timely responses to competent authorities and health ministry’s regarding product performance.
• Co-ordinating responses to product performance enquiries from surgeons, patients and health care providers.
• Support litigation cases and co-ordinate the provision of performance data to DePuy legal teams
• Partner with DePuy manufacturing sites and design centres to obtain product performance summaries and data.
• Undertake product performance reviews using available data analysis tools to respond to enquiries.
• Escalate product performance concerns through the established processes
• Participate in product risk assessments providing input in order to evaluate patient risk as required
• Representing DePuy, be pro-active in shaping and influencing regulatory environment working with Healthcare Industry body groups and Forums (ABHI, Eucomed etc).
• Attend meetings with health care regulators as required.
• Perform all other work-related duties
• Continuous Improvement Focus
• Additional activities as deemed appropriate by the Complaints Manager.
To be part of this high performing team you will have:
• A minimum of a Bachelor’s Degree is required.
• Regulatory/Quality Systems experience
• 3+ years Medical Devices Industries experience
• Broad experience and knowledge of world-wide quality system regulations (e.g. FDA 803, 820; ISO 13485, ISO 14971) with a working knowledge of international Health Authority reporting requirements
• Demonstrated proficiency conducting investigations and implementing corrective and preventive actions
• Ability to work in a cross-functional and matrix environment.
• Actively participates in cross-functional team meetings.
• Requires organizational and critical thinking skills.
• Ability to prioritize and multi task.
• Demonstrates ability to respond to the urgent needs of the team, with proven track record of meeting deadline.
• Problem solving
• Strong verbal and written communication skills
• Knowledge of basic medical terminology.
• Proficient in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint).
• Ability to interface with technical and non-technical personnel at all organization levels.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each:
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Rare in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Depuy (Ireland) Limited (7386)