Senior Quality Engineer - Galway

Senior Quality Engineer

Location: Galway

Duration: 12 months

Hours: 39

Pay rate range: depending on experience

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!

roles and responsibilities

To provide QA technical and compliance expertise as part of teams tasked with establishing and assuring system and product quality objectives. Assure compliance to applicable regulations. Lead quality activities such as audits, procedure development, product release, documentation review and define changes to controlled documents. Provide QA technical and compliance support for products and manufacturing related to suppliers, corrective and preventive actions,

product/process improvements and training. This will involve: 

• Leads and/or facilitates compliance and improvement activities associated with the Neuravi quality system (e.g. CAPA, audit programs, personnel training).

• Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Plan, execute, report and follow-up on quality system audits.

• Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations

• Resolves project issues by working with team members, suppliers, and others as appropriate.

• Reviews and approves operational, test and validation data to establish conformance to technical specifications and performance standards for existing, new or modified products

how to succeed

Experience in the QA activities associated with a manufacturing environment including project

management skills and leadership ability, results and deadline driven, excellent interpersonal skills and good judgment / problem solving skills. You will also bring:

• Minimum Bachelor's Degree in Engineering, Science or related technical field.

• 5 years minimum QA, Quality System or regulatory experience in the medical industry

• Experience using systems such as CAPA, document management systems, audit programs, personnel training highly preferable  

• Prerequisite auditor certification from an industry recognized organization is beneficial.

• Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the

• European Medical Device Directive, and the Canadian Medical Device Regulations.

• Experience in preparation for notified body and FDA inspections.

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 months. Hybrid working.

you are welcome here

Cerenovus 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 Cerenovus

Cerenovus is part of Johnson & Johnson MedTech and an emerging leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. At Cerenovus we offer a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. Contribute to the next healthcare breakthrough with your next project at Cerenovus. 

https://www.jnjmedtech.com/en-US/companies/cerenovus

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”.