Senior Quality Engineer

Senior Quality Engineer

Location: Cork

Duration: 12 months

Hours: 39

The role involves utilizing Quality Engineering tools and practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.

Roles and Responsibilities

• Team member representing the Quality function supporting projects in with a focus on metals forming processes.

• Support Quality and Validation activities for process improvement projects, product transfers and new product introductions.

• Responsible for ensuring conformance with current equipment, process, and systems validation regulations.

• Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.

• Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).

• Determine process inputs and factors for variation where process capability is required.

• Responsible for conducting/reviewing Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.

• Responsible for conducting Test Method Validations as required

• Develop/Review Risk documentation to support processes as part of Validation process

• Partner with other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.  

• Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs. Escalation of quality issues as appropriate.

• Support root cause analysis activities.

• Communicate effectively with internal team on actions and deliverables.

• Provide timely and accurate reporting and management of escalations as appropriate on project activities.

• Ensure all activities comply with GMP, ISO and quality system requirements.

• Ensure that all health, safety and environmental requirements are fulfilled.

How to Succeed

ESSENTIAL:

• BSc in Engineering or Science with >3 years’ experience in a medium to high volume manufacturing environment 

• 2 year in a similar capacity in a regulated industry (i.e. FDA/ISO)

DESIRABLE:

• Experience working in both an FDA and European regulatory environment is preferred with an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.

• A thorough understanding of GMP/ISO and validation regulations. 

• Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.

• Problem solving engineering expertise (Six Sigma, SE or A3)

• Strong verbal and written communication skills 

Benefits

This role offers a very competitive hourly rate. This contract will run for 12 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-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. 

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”.