About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers 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 are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Job Details
Job Function: Supply Chain Engineering
Job Sub Function: Quality Engineering
Job Category: Scientific/Technology
Location: Blackpool, Lancashire, United Kingdom
Purpose
Part of the Quality team reporting into the Quality Engineering Team Leader. This role provides Quality Engineering support to site manufacturing processes in Base Business by maintaining and developing the Quality System. This includes the procedures and records required for the development, validation and production of CMW products and processes in order to assure the ongoing quality of products and maintain compliance with ISO 9000, ISO13485, FDA QSRs and the Medical Devices Directive.
Key Responsibilities
* Perform monthly trending of non-conformances and generate data as is required for Dashboard reviews.
* Ensure all assigned quality actions are investigated, have causes identified and actions plans completed to the agreed schedule.
* Lead investigations into product or process issues raised, identifying root cause and corrective action plans as required.
* Partner with Engineering team during the definition and introduction of new or improved processes, delivering all validation, calibration, risk management and documentation needs.
* Own Validation Master Plan and Quality validation review activities for site production processes.
* Support operations and engineering teams to ensure that Preventive and Corrective Maintenance activities are completed to schedule.
* Work with operations partners on process improvement activities including Lean Manufacturing activities.
* Present business related issues or opportunities to next management level where the need arises.
Qualifications / Requirements
* A minimum of a degree in a scientific or engineering field.
* A minimum of 3 years of experience in a quality, technical, or manufacturing role within a regulated industry.
* Well-developed interpersonal and collaboration skills.
* Solid understanding of ISO 9001, ISO 13485, and FDA Quality System Regulations is preferred.
* Understanding of Good Manufacturing Practice (GMP).
* Previous exposure to quality systems, including ISO 13485 and FDA QSRs.
* In-depth knowledge of validation and change control processes.
* Knowledge of quality tools such as FMEA, root cause investigation, Lean, and Six Sigma methodologies.
* Strong computer literacy.
* Ability to apply structured problem-solving and make informed decisions.
* Ability to communicate effectively across multiple levels of the organization.
* Ability to build and maintain positive working relationships.
* Demonstrated understanding of AI concepts and frameworks, including responsible and ethical AI practices, with experience using effective prompt generation to improve efficiency and productivity.
Equal Opportunity
We are committed to creating an inclusive work environment where all employees can thrive. We offer competitive compensation and benefits, along with opportunities for learning, development, and career growth. We are an equal opportunity employer and provide reasonable accommodations throughout the recruitment process.
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