Senior Quality Engineer

Senior Quality Engineer - DePuy Synthes

Location: Blackpool

Hours: Full time. This role will be mostly on-site (4 days a week) with 1 day working from home

Duration: 12 months initially with likely extensions

Imagine your next project as a Senior Quality Engineer, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

Reporting to the NPI QE Leader, the Senior Quality Engineer (projects) will be responsible for quality assurance leadership for product and process transfer, system implementation and readiness for strategic network projects in Blackpool. 

The job holder will lead the QA element of process / technology and product transfers in conjunction with local Quality, Engineering, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion. This will involve: 

• Represent Quality as part of a cross functional team to ensure delivery of projects (transfers and new technology) 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. 

• Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all Product transfers 

• Lead Design for Inspection activities for all Product transfers 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. 

• 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 developing, reviewing and approving product, gauge, tooling and fixturing drawings. 

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.

how to succeed

• University Bachelor’s (or equivalent) degree in Engineering is required. Other Advanced degree or a degree with a focus in Science, Computer Science, or digital area may be acceptable.

• A minimum of 4 years of experience in a regulated industry (MedTech or Pharmaceutical/ Medicine) with a minimum of 2 years of experience in Quality Engineering.

• Proven ability to successfully introduce new products in the Medical Device Industry. 

• Experience and a proven track record of implementing appropriate risk mitigation

• Experience in Process Mapping, Equipment Qualification and Test Method Validation, Capital Evaluation projects, Final Acceptance, Change Management, Nonconformance. 

• Understanding of the regulatory requirements for a commercial release (MDSAP, MDD, MDR, FDA, and ISO standards)

• In-depth knowledge of Product/Process Risk Management 

• Prior experience in Process / Manufacturing Quality is an asset.  

• Prior experience with GD&T, Six Sigma, Lean Manufacturing, Continuous Improvement, Project Management is an asset.

• Experience in Product/Process Transfer, Defining Business Requirements, System Integration/Enhancement, Product and Process verification and Validation.

• Strong communication, teamwork, problem solving and decision-making skills

• Project management skills

benefits

This role offers a very competitive hourly rate. 

This contract will run for a 12 month duration and has a strong chance of extension. 

you are welcome here

DePuy Synthes 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

https://www.jnjmedtech.com/en-GB/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. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

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”.