Quality Validation Engineer

Supplier Quality Engineer

Location: Ringaskiddy, Cork, Ireland

Duration: End of 2026

Hours: Full time hours

Work style: Hybrid, 3 days on-site

Travel: Travel will be required across Europe to various sites. Around 1 week out of every 2-3 months

Imagine your next project as a Supplier 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

To provide Source Quality expertise, direction and guidance to the DePuy Synthes of companies in line with established corporate and regulatory standards. Provide support to the Global Supply Chain organisation through the provision of supplier information, performance data and metric. Responsible for implementation of External Manufacturing Quality Systems to support outsourcing of products ensuring Quality, Operational, Process Improvement and Product Development/Transfer issues and projects are implemented in an efficient and effective manner that minimizes risk and assures equivalent Quality levels are maintained. This role will provide Quality Leadership for the outsourcing of both components and finished devices to Preferred and External Manufactures (EMs). Ownership will include supplier manufacturing through final release to distribution and response to field complaints of the finished device. This will involve: 

• Quality point of contact for Global Supply Chain with select Suppliers and EMs as part of the Supply Base Optimisation Team

• Work at select Preferred Supplier and EM locations to

  • Produce advanced quality planning documentation

  • Conduct Process Capability Studies,

  • Drive cost improvement with the use of PE tools

  • Develop and manage First Article Inspections as required at suppliers or within DePuy

  • Develop supplier capability in risk assessment such as PFMEA

  • Manage training and certification of operators and inspectors to CTQs with the suppliers as required

  • Develop and implement efficient and effective inspection points and control plans at the supplier

• Actively support all defined External Manufacturing Quality Systems goals and objectives.

• Conduct on-site quality and process assessments at preferred and EM suppliers both to approve new suppliers and on an on-going basis

• Review, guide and approve Medical Device Validation of new/changed production processes in accordance with J&J requirements and ISO 13485 as required

• Design and validate Quality System processes where appropriate (CSV and Inspection Process)

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

• Ensure suppliers continue to meet DePuy Quality requirements with regard to PR120-009 compliance

• Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance

• Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc.

• Ensure effective and timely closure on all Supplier Failure Investigation Reports.

• Maintain standards of housekeeping & GMP requirements

• Represent the Source Quality function as required by management.

• Ensure that all Health, Safety and Environmental requirements are fulfilled.

how to succeed

You will have excellent communication skills, have a pro-active approach , ability to interpret, communicate and work from drawings and specifications. You will be a team player and have strong influencing and negotiation skills. You will also bring:

• Degree level qualification or equivalent in an engineering or science-based discipline

• Minimum 5 years’ experience in a senior Quality or Engineering Function within Medical Devices

• ISO 13485 and QSR (or related sector specific standard) lead assessor qualification

• Experienced in SPC, Advanced Quality Planning, Product Validation (essential) and ISO 13485.

• Strong experience in validation is important for this role

• Knowledge of applicable production processes

• Previous experience of product transfers/start up

• Willingness to travel

• Strong in root cause analysis skills

• Strong communication, teamwork, and problem-solving skills

• Demonstrated ability to lead improvement projects with suppliers

details

• This role offers a very competitive hourly rate. 

• This contract will run until the end of 2026.

• This is a hybrid role (3 days on-site in Cork, Ringaskiddy)

• Traveling across Europe will be required for this role. Typically this could be up to a week, every 2-3 months depending on needs. 

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, LTD & 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”.