Overview
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation enables us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we innovate across the full spectrum of healthcare solutions to deliver breakthroughs of tomorrow and impact health for humanity.
Learn more at https://www.jnj.com
Job Function
Quality
Job Sub Function
Quality Systems
Job Category
Professional
All Job Posting Locations
Leeds, West Yorkshire, United Kingdom
Job Description
About Orthopaedics
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Orthopaedics? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Role Summary
We are searching for the best talent for the Quality Systems Analyst position to be in Leeds, UK.
Purpose
This role is responsible for ensuring compliance with documented control procedures and records management processes for the site. The role must ensure that relevant documentation (procedures and specifications) are followed to guarantee compliance with Global Medical Device Standards and Regulations.
Responsibilities
* Perform batch record review, correction, and associated document control activities for Manufacturing and Customs products.
* Release all Leeds production lots.
* Work closely with Operations and Planning Teams to ensure complete, accurate, and timely batch records.
* Champion the delivery of GDocP reduction and report GDocP trends monthly.
* Manage and store DHR documentation to ensure full traceability.
* Control the Quality Assurance archive, and batch archiving and scanning activities.
* Conduct Quality System investigations, action planning and execution as assigned by management.
* Conduct Quality System monitoring, trending and reporting as assigned by line manager.
* Provide current and historic DHRs as required by customer quality/vigilance/regulatory/auditors.
* Participate in Site Continuous Improvement activities as identified by line management.
* Support site preparedness for third-party audits and participate in internal and external audits, supporting front and back room activities as needed.
* Follow company, HSE and quality standards to enable the site to achieve excellent results.
* Carry out such further tasks as may be delegated by the immediate Manager.
Qualifications / Requirements
Minimum Requirements
* A Levels (or equivalent) plus GCSE (or equivalent) in English and Mathematics.
* Minimum of 2 years of experience in the Medical Device or Healthcare industry, or another similar regulated industry.
Desirable
* Experience in Quality Assurance, including batch record review, documentation control, and audit support.
* Demonstrated knowledge of manufacturing principles, practices, and procedures.
Required Experience And Skills
* Proven ability to perform effectively in a fast-paced, high-pressure environment, meeting tight deadlines while maintaining accuracy and quality.
* Well-developed organizational skills with the ability to work independently when required.
* Strong attention to detail and excellent time management.
* Ability to work effectively as part of a team to achieve results.
* Versatility – ability to grasp technical detail outside own specialty.
* Good numerical and literacy skills.
* Ability to read and follow written instructions.
* Computer literacy.
What to Expect in the Hiring Process
We want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
* Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
* Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team members to understand more about you and answer any questions.
* Staying informed: Our recruitment team will keep you updated on what to expect at each step.
* Final steps: For successful candidates, you will need country-specific checks before starting. We will guide you through these.
Finally, at the end of the process, we’ll invite you to provide feedback in a short survey to help us improve the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process!
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