Quality Systems Analyst

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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About Orthopaedics

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics Ready to join a team thats reimagining how we heal 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 & 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 as may be required 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 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.

We are searching for the best talent for the Quality Systems Analystposition to be in Leeds UK.

Purpose:

This role is responsible for ensuring compliance with document control procedures and records management processes for the site. This role must ensure that relevant documentation in the form of procedures and specifications are followed to guarantee compliance with Global Medical Device Standards and Regulations.

As a Quality Systems Analyst you will:

• Perform Batch record review correction and associated document control activities for Manufacturing and Customs products.

• Release of all Leeds production lots.

• Work closely with Operations and Planning Teams to ensure the delivery of complete accurate and timely batch records.

• Champion the delivery of GDocP reduction and reporting GDocP trends on a monthly basis.

• Manage and store DHR documentation effectively to ensure full traceability.

• Control of the Quality Assurance archive and batch archiving and scanning activities.

• Conduct Quality System investigations action planning and execution activities 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 functions.

• Participate in Site Continuous Improvement activities as identified by line management.

• Support site preparedness activities for all third party audits. Participate in Internal and External Audits supporting front and back room activities as needed.

• Follow company H S & E and quality standards to enable the site to achieve excellent results.

• Cary out such further tasks that maybe delegated by the immediate Manager.

Qualifications / Requirements:

Minimum requirements:

• A Levels (or equivalent) plus GCSE (or equivalent) in English and Mathematics.

Desirable:

• 2 years experience in the Medical Device or Healthcare industry or similar regulated industry.

• Demonstrated knowledge of manufacturing principles and practices and procedures.

Required experience and Skills:

• Well-developed organizational skills with an ability to work independently when required.

• Attention to detail and excellent time management.

• The ability to work to a deadline to cope under pressure and react to changing requirements.

• In addition the ability to work as part of a team to achieve results.

• Versatile readily grasps technical detail outside own Specialty.

• Good numerical and literacy skills.

• Ability to read and follow written instructions.

• Computer Literacy.

At Johnson & Johnson 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.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.

• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

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