Job Function
Supply Chain Engineering
Job Sub Function
Quality Engineering
Job Category
Scientific/Technology
All Job Posting Locations
Blackpool, Lancashire, United Kingdom
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
Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position must perform monthly trending of non-conformances and generate data as is required for Dashboard reviews. It will ensure all assigned quality actions are investigated, have causes identified and action plans completed to the agreed schedule, regardless of source.
The Quality Engineer is responsible for leading investigations into product or process issues raised, identifying root cause and corrective action plans as required. They will also partner with Engineering team during the definition and introduction of new or improved processes, delivering all validation, calibration, risk management and documentation needs. As an outcome, the Quality Engineer will own Validation Master Plan and Quality validation review activities for site production processes.
They will support operations and engineering teams to ensure that Preventive and Corrective Maintenance activities are completed to schedule and work with operations partners on process improvement activities including Lean Manufacturing activities.
Where the need arises, they are responsible for presenting business related issues or opportunities to next management level.
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 relationshipsDemonstrated understanding of AI concepts and frameworks, including responsible and ethical AI practices, with experience using effective prompt generation to improve efficiency and productivity
Benefits
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.
Preferred Skills
- Customer Centricity
- Data Savvy
- Document Management
- Execution Focus
- Good Automated Manufacturing Practice (GAMP)
- Issue Escalation
- Lean Supply Chain Management
- Process Control
- Process Improvements
- Quality Control Testing
- Quality Services
- Quality Standards
- Quality Systems Documentation
- Science, Technology, Engineering, and Math (STEM) Application
- Supervision
- Supply Planning
- Technologically Savvy
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