Quality Technician

Quality Technician

Location: Galway

Working mode: Hybrid

Duration: 6 months (opportunity for a contract extension)

Hours: 39 hours per week

Pay rate range: Competitive hourly rate (PAYE, Umbrella and Ltd options available)

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.

roles and responsibilities

In accordance with all applicable federal, state and local laws/regulations and Corporate  Johnson & Johnson, procedures and guidelines, this position: 

• 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 Neuravi/Johnson & Johnson policies, procedures and applicable  regulatory requirements, identifying and implementing process and system improvements as  applicable. 

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

• Supports with preparation and execution of quality system audits (supplier and internal)

• Actively participates in and supports departmental activities and responsibilities in accordance  with existing procedures and external regulations. 

• Makes decisions that are aligned with management objectives regarding work processes,  plans and schedules to achieve quality objectives. 

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

• Participates in resolution of project issues by working with team members, management,  suppliers, and others as appropriate. 

• Assists department and project leaders in collating assigned 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. 

• Performs other duties assigned as needed: 

• Responsible for communicating business related issues or opportunities to next management  level

• Responsible for following all Company guidelines related to Health, Safety and Environmental  practices as applicable. 

• 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 a 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 co-workers and the public. 

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

• Demonstrates an ability to apply, recommend and/or create quality tools and apply them effectively  to a variety of business situations related to production, project and team environments.

• 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.  

• Good interpersonal skills and ability to work with people to achieve results. • Good written and communication skills, fluency in English. 

• Good judgment/decision making and problem-solving ability, capable of understanding the impact  of decision making on both Neuravi and their customers. 

• Motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team 

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months and has a strong chance of extension. 

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. 

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”.