Senior Source Quality Engineer

Senior Source Quality Engineer

Location: Cork

Duration: 18 months

Hours: 39

Johnson & Johnson MedTech is recruiting for a Senior Source Quality Engineer.

Johnson & Johnson MedTech 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. 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.

Roles and Responsibilities

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

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

- Supplier Approval & Qualification.

- Supplier Development including Robust process implementation and InspectionReadiness.

- Change control management and qualification of supplier process changes and supplier transfers 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).

- Project management – planning, scheduling, tracking and execution of project activities as part of supplier and part qualification.

- 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;

- Identify requirements for product approvals, transfers or obsolescence.

- Execute product equivalency assessments.

- Lead PVE with responsibility for associated documentation.

- Escalate timeline risk with mitigation recommendations.

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

- 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

How to Succeed

- 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 trainings an asset.

- Work travel requirements ~ 10%.

Benefits

This role offers a very competitive hourly rate. This contract will run for a 18 months.

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-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, LTD & 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".

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