Johnson & Johnson Careers
Quality Systems Engineer
Leeds, United Kingdom
Requisition ID: 1805643488W
Role: Quality Systems Engineer
Location: Leeds, United Kingdom.
Reports to: Quality Operations Manager
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
REPORTING TO THE QUALITY OPERATIONS MANAGER, THE PRIMARY PURPOSE OF THE QUALITY SYSTEMS TEAM LEAD IS TO LEAD PROFESSIONALS IN THE QUALITY SYSTEMS TEAM. THE ROLE IS ALSO RESPONSIBLE FOR THE OVERSIGHT OF COMPLIANCE ACTIVTIES AND SYSTEMS FOR THE SITE AND FOR IDENTIFYING OPPORUTINTIES FOR IMPROVEMENT WITHIN QUALITY.
What you’re great at:
• Are you innovative, tenacious and passionate about Quality?
• Performance and results driven.
• Culturally aware and politically sensitive.
• A team player.
• Good influencing skills.
• Project Management skills.
• Good generalist (experienced quality person).
• Good communicator.
As a Quality Systems Engineer, your typical day may include:
• Lead, mentor and develop a team of professionals in the Quality Systems Team to meet business needs and succession plans.
• Continuous Improvement Focus - Lead compliance improvements, which may result from Quality System Review trends and other transformational projects.
• 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.
• Encourage, support and direct initiatives and programs that head to improved quality and improved regulatory compliance.
• 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. Resolve potential compliance issues with functional Managers / Leaders.
• Lead the Corrective Action and Preventive Action system so this it is maintained in a manner compliant with local and WW procedures, ISO, QSR and Corporate Requirements.
• Lead the Non-conformance (NC) system so that it is maintained in a manner compliant with local and WW procedures and ISO and QSR and Corporate Requirements.
• 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.
• Support improvement opportunities and resources for the ADAPTIV PLM across the site and build on the improvements already made in previous PLM systems.
• Continue to develop strong working relationships at all levels of the business both internally and externally and ensure that the training needs of the site end users for the ADAPTIV PLM are met.
• Ensure that there are sufficient resources available to support activities such as Device History Record (DHR) review prior to QA Release and for the co-ordination of DHR archiving activities at the site in compliance with the records retention policy.
• 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.
• Support and chair the Quarterly Quality Management System Review in terms of preparation for these meetings and ensuring that any trends/ issues noted are challenged and acted upon.
• Manage Close Call and Stop Shipment activities for the site.
• Support the internal audit system to both local procedures and expectations of ISO 13485:2003, EN ISO 13485:2012, ISO 14971:2007, EN ISO 14971:2012, CFR Title 21 Part 820 Quality System Regulation 1996 and other regulatory standards outlined in SEP-180.
• Support the unannounced audit preparedness process and ensure that there are resources available to support external regulatory audits and inspections.
• Assist the Quality Operations Manager in the management of regulatory compliance program to include FDA and BSI regulations.
• Partner with other DePuy Synthes sites/ operating companies to ensure harmonization and alignment with J&J Quality Policies, Guidelines, Programs and Systems.
• Support the DePuy Synthes Quality Systems integration process.
• Ensure compliance with all regulated requirements as outlined in SEP-180.
• Maintain a high level of housekeeping in designated areas and observe all HS&E requirements.
• Operate within the company’s standard operating procedures where applicable, review, maintain and create appropriate procedures for sphere of activity.
• Maintain a good level of housekeeping in designated areas, and observe all HS&E requirements.
To be part of this high performing team you will have great attention to detail and have
• A degree level or similar qualification in a science, mechanical or industrial engineering discipline.
• Minimum 5 years’ experience in a senior quality role within a regulated industry with a minimum of 2 years’ experience in a leadership position.
• Proven ability to successfully manage projects and key site Quality initiatives.
• Proven knowledge of FDA, ISO and MDD GMP requirements regarding medical devices.
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.
We respectively request Government Officials to identify themselves as such on application; for the Foreign Corrupt Practices Act. 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 based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Depuy Int'l Ltd. (8722)