Quality Technician

Quality Technician

Location: Galway, Ireland

Duration: 9 months 

Hours: 39 hours per week. Hybrid (3 days on-site)

Imagine your next project as a Quality Technician, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

The Quality Technician will provide QA/QC technical and compliance expertise as part of teams tasked  with establishing and assuring system and product quality objectives. The Quality Technician will assure compliance to applicable regulations and J&J Quality Standards and  perform quality activities such as data analysis, QMS audits, procedure development, product release,  documentation review and implementation of changes to controlled documents.  

• Provides QA technical and compliance support for products and manufacturing related to  suppliers, corrective and preventive actions, product/process improvements and training.

• Monitors compliance to Cerenovus/Johnson & Johnson policies, procedures and  applicable regulatory requirements, identifying and implementing process and system  improvements as applicable

• Identifying, prioritizing,  communicating, and resolving quality issues.  

• Plans, executes, reports and follows-up on quality system audits (internal)

• Tracks and reports progress across projects and departmental commitments by reviewing  schedules and due dates, identifying risks, and assisting teams with contingency plans.

• Assists department and project leaders in developing and reporting appropriate  performance and quality metrics.

• Reviews and approves manufacturing, test, and validation data/records to establish  conformance to technical specifications and performance standards for existing, new or  modified products and processes. 

• Support and facilitate the administration of the Windchill documentation management system  and overall change control process. 

• Responsible for ensuring personal and Company compliance with all Federal, State, local and  Company regulations, policies, and procedures. 

• Performs other duties assigned as needed. 

how to succeed

• Bachelor’s degree in engineering, Science or related technical field preferred.

• 1-year minimum QA, Quality System, or regulatory experience in the medical industry is preferred.  

• Knowledge of the preparation for notified body and FDA inspections advantageous.

• Knowledge of the QA activities associated with a manufacturing environment including  project management skills. 

• Proficient in basic IT skills relevant to the applications related to the tasks assigned, i.e.  the use of word processors and similar windows-based applications, e.g. MS Office  products. 

• Ability to achieving results within assigned deadlines with an ability to handle multiple  tasks and operate in a fast-paced environment. 

• Ability to work cooperatively with coworkers and the public. 

• Ability to perform duties in accordance with policies and procedures and to comply with  civil rights requirements. 

• Good interpersonal skills and ability to work with people to achieve results.

• Good written and communication skills, fluency in English. 

• Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the  European Medical Device Directive/Regulation. Knowledge of other applicable medical  device regulations, e.g. Brazilian, Canadian, Australian, Japanese, Korean, etc.,  advantageous.  

benefits

This role offers a very competitive hourly rate. This contract will run for a 9 month duration. This is a hybrid position, 3 days on site and 2 days at home. 

you are welcome here

Cerenovus J&J 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”.