Senior Source Quality Engineer

Senior Source Quality Engineer 

This is a hybrid role and you will be required to visit suppliers when needed, but can work remotely when not visiting suppliers. Travel includes Limerick & Clare. 

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative,  comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. 

Duties and Responsibilities:

• Provide overall quality assurance leadership in the management of suppliers engaged in the production of Johnson and Johnson products. 

• Provide complex product team support for quality system design and audit compliance assessment, and support of steady state manufacturing processes. 

• Supplier Development including Robust process implementation and Inspection Readiness. 

• Change control management and qualification of supplier process changes and supplier transfer programs. 

• Supplier Process validation and approval in line with internal and Regulatory requirements.

 • Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO). 

• Promote continuous improvement and Process Excellence activities within the Global

Supply Chain  

• Resolve problems & eliminate constraints to ensure project and supply targets are met.  

• Work with the Sourcing teams to ensure the supply base is optimized to reflect the most efficient processes; 

o Identify requirements to transfer identified products to the alternate supplier or obsolete product. 

o Execute product equivalency assessments. 

o Lead PVE with responsibility for associated documentation. 

o Escalate timeline risk with mitigation recommendations. 

o Collaboration with internal cross-functional team members and suppliers on timeline  execution for SQE responsibilities.

o Liaise with internal stakeholders to ensure any supplier-based decisions are understood  and accepted at site level. 

• Connect – Interface with partners in Source, R&D Engineering, Manufacturing Engineering, Receiving Inspection, Manufacturing Quality Engineering, Quality Systems and suppliers serving  multiple industries. 

• Shape – Challenge critical thinking skills by solving supplier challenges, such as timely material  qualification/maintaining production yield, while simultaneously navigating quality system  requirements, engineering best practices, and supply chain demand. 

• Lead – Take accountability for supplier qualification and performance by developing strong relationships with supplier executive leaders to drive improvements throughout the value chain. 

• Deliver – Manage deliverables in a fluid environment with varying levels of complexity while  maintaining alignment with multiple stakeholders 

Experience Required:

• A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline. 
• A minimum of 5 years of experience in a highly regulated industry is required.
•  Experience in the Medical Device industry and/or Pharmaceutical industry is required.
• FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required.  
• Six Sigma, Lean, or Lead auditor Certification and training an asset. 

We will consider candidates from other highly regulated industries who do not have Med Device or Pharma experience for this role!

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application. 

If you would like some additional information about the role please contact: Tabitha.crabtree@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”.