Quality Engineer

Senior Quality Engineer

Location: Ringaskiddy, Cork

Duration: 12 months

Hours: 39

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!

Role overview:

The Senior Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff.

The Senior Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. 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 capability of processes. This person will support processes in base business.

Major Responsibilities & Duties:

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

• Conduct benchmarking to develop more effective methods for improving quality

• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs

• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.

• Champions compliance to applicable Global Regulations and standards

• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.

• Supports new product introduction as part of design transfer

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

• Approve IQ, OQ, PQ, TMV or Software Validation

• Ensures effective quality strategies are created for the validation of test methods, process and design.

how to succeed

The successful candidate will have a strong Continuous Improvement Focus, will be a good problem solver and will have the ability to perform “hands on” troubleshooting. The will also have the ability to think on their feet and provide sound judgment. Also required:

• A minimum of a Bachelors Degree, preferably in Engineering or related technical field

• Generally requires 4-6 years related experience.

• Experience working in both an FDA and European regulatory environment is preferred.

• This position will require relevant experience working in manufacturing/operations.

• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.

• Experience with a proven track record of implementing appropriate risk mitigation.

• Technical training and experience using Statistics, Lean and Six Sigma

• Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.

• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.

• The ability to think on the feet and providing sound judgment is highly desired.

• Good technical understanding of manufacturing equipment and processes is required.

• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.

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

• Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.

• Demonstrated project management and project leadership abilities are required.

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 months and has a strong chance of extension. 

you are welcome here

DePuy 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

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”.