Quality Engineer in Blackpool

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Description:

We are searching for the best talent for Process Quality Engineer.

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.

You will be responsible for:

• Performing monthly trending of non-conformances and generating data as required for Dashboard reviews.
• Ensuring all assigned quality actions are investigated, have causes identified and action plans completed to the agreed schedule.
• Leading investigations into product or process issues raised, identifying root cause and corrective action plans as required.
• Partnering with the Engineering team during the definition and introduction of new or improved processes, delivering all validation, calibration, risk management and documentation needs.
• Owning Validation Master Plan and Quality validation review activities for site production processes.
• Supporting operations and engineering teams to ensure that Preventive and Corrective Maintenance activities are completed to schedule.
• Working with operations partners on process improvement activities including Lean Manufacturing activities.
• Presenting business-related issues or opportunities to the next management level when necessary.

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.

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.