Project Quality Engineer

Location: Leeds, UK

Duration: 6 months

Hours: 37 hours

Imagine your next project where you will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and DePuy R&D personnel ensuring timely communication to all stake holders to effect successful project completion.

roles and responsibilities

• Represent Quality as part of a cross functional team to ensure delivery of projects into production with the highest level of quality, compliance, and adherence to timelines
• Compile and execute validation protocols for new product/processes and software.
• Ensure correct implementation as per standard validation procedures.
• Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
• Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production
• Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
• Liaise with R & D to ensure Critical to Quality Characteristics are agreed and documented for New Product Development
• Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.
• Lead QA input to Design for Manufacture activities on site.
• Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during all day to day
• Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
• Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing.
• Assist in the development, review and approve product, gauge, tooling and fixturing drawings.
• Maintain a good level of house-keeping in designated areas, and observe all Health and Safety at work requirements.

how to succeed

• A degree level or similar qualification in mechanical or industrial engineering.
• Minimum 2 years experience in a quality role within a regulated industry.
• Proven ability to successfully introduce new product development in the Medical Device Industry.
• Proven knowledge and ability regarding product verification and process validations.
• Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
• Proven experience and training in Mechanical Engineering processes.

Key competencies require:

• Culturally aware
• Flexible
• Team player
• Good influencing skills
• Project Management skills
• Good generalist (experienced quality person)
• Methodical
• Defuser, not inflamer
• Good communicator
• Politically sensitive

Benefits

This role offers a very competitive hourly rate. This contract will run for a minimum of 6 months.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about DePuy Synthes

DePuy Synthes is the orthopaedic and neurological businesses of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare company. At DePuy Synthes we specialise in our innovations in healthcare products, services and programs that make a real difference to millions of people across the world. We specialise in joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, and also the VELYS™ Digital Surgery portfolio. Contribute to the next healthcare breakthrough with your next project at DePuy Synthes.

https://www.jnjmedtech.com/en-US/companies/depuy-synthes

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. PAYE & Umbrella options are available.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.