Design Quality Engineer

Design Quality Engineer

Location: Cerenovus, Galway - Hybrid

Duration: 12 Months

Hours: 40 per week

Pay rate range: Depending on experience 

Imagine your next project Providing QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. Assures compliance to applicable regulations and completes quality activities such as risk assessments, device testing, QMS/data audits, procedure development, documentation review and changes to controlled documents. 

Provides design control, risk management and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements and complaint investigations

roles and responsibilities

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

• Responsible for ensuring CERENOVUS Design control and Risk Management activities, wherever they are performed comply with the requirements of the Cerenovus Design Control and Risk Management processes.

• Provides Quality support/guidance to R&D and Lifecycle Management projects leads/team members.

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

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

• Manages and maintains the records related to design control applicable to product development and design/manufacturing change projects.

• Contributes and participates in design review meetings.

• Provides input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.

• Provides input into development of protocols / reports supporting the Design control process.

• Provides input and review to protocols and reports for sterilization, biocompatibility and packaging validations.    

• Co-ordinates the timely review and approval of all details in R&D batch sterilization records as meeting the requirements of the cycle validated and appropriate for the CERENOVUS product.

• Co-ordinates the review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design reports.

• Supports bench test activity as required.

• Supports the translation of the design requirements into manufacturing requirements.

• Ongoing monitoring of data from Quality Management systems and provision of immediate feedback to quality management on deviations or issues of concern. 

• Administration and management of CERENOVUS systems for CAPA, non-conformances and for supplier corrective actions.

• Leads and/or facilitates compliance and improvement activities associated with the Quality System (e.g. CAPA).

• Prepares data as applicable for use in management review.  

• Supports internal/Supplier audits as applicable.

• Supports regulatory activities as requested by management.

• Represents Cerenovus professionally and positively externally to agencies, vendors and regulators.

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

• 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

• Minimum education of degree in a technical field is preferred. 

• Minimum 3 years’ experience in the medical device industry and/or IVD/pharmaceutical preferred.

• Knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes beneficial.

Required knowledge, skills and abilities

• Knowledge of basic QMS requirements and processes.

• Knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device quality system requirements.

• Ability to discern major quality issues.

• Ability to work well under deadlines and pressure.

• Ability to work on own initiative and as a team player.

• Ability to build good, strong and positive working relationships with cross functional teams internationally.

• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 Months and has a 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. 

questions

If you would like some additional information about the role please contact: Tabitha.Crabtree@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”.