Quality Manager

Quality Manager

Location: Galway, Ireland

Duration: 12 - 14 months

Hours: 40 hours per week

Imagine your next project as a Quality Manager, 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 Manager is responsible for supporting the manufacturing of product in compliance with the Neuravi’s Quality System.

This role executes on quality strategy and direction as determined and communicated by Neuravi Management directly and in quality procedures. The Quality Manager ensures that the Site Head of Quality and senior management are immediately informed of shortcomings, changes in strategy or deviations from agreed plans and/or the established quality system by subcontractors providing services important to the production of Neuravi product. This will involve: 

• Management of the subcontractor and vendor system including coordination of initial assessments, professional maintenance of files and periodic review and ongoing assessment.

• Ensuring all personnel involved in the manufacture of Neuravi product including subcontractor staff have appropriate training in quality, procedures and completion of paperwork prior to working on the production of Neuravi product.

• Ensuring Neuravi production, wherever it is performed, is in compliance with appropriate, approved and current contracts and procedures.

• Coordination of scheduling and documentation of product movement between subcontract assembler and subcontract sterilizer including the scheduling of routine sterilization cycles.

• Timely review and approval of all details in batch sterilization records as meeting the requirements of the cycle validated and appropriate for the Neuravi product.

• Timely review and approval of production records and sterilization records prior to release of each batch of product.

• Responsible for final product release in compliance with the quality system requirements.

• Day to day interface and communication with the subcontract assembler

• Definition and management of an appropriate program for Neuravi oversight of routine monitoring and management of the product bioburden. 

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

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

• Management of the Neuravi Calibration system.

• Manage the maintenance and records of the Neuravi Process Validation system.

• Preparation of data on production, environmental monitoring, vendor assessment, non-conformances and supplier corrective actions for use in management review. 

• Acting as an audit escort and/ or support coordination of backroom activity during inspections as required.

• Co-ordinate internal audit schedule and internal audit records.

• Support bench test activity as required, contribute and participate in design review meetings.

• Coordinate product movement and document the chain of control from manufacture to test for each unit used in product testing.

• Where required provide input and review to protocols and reports for sterilization, biocompatibility and packaging validations.   

• Where required provide contribution towards the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.

• Support regulatory activities as requested by management.

• Compile and conduct quality training for employees as directed,

• Represent Neuravi professionally and positively externally to agencies, vendors and regulators.

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

•  For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if 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

• Minimum education of degree in a technical field. 

• Minimum 5 years’ experience in the medical device industry, with at least three years in a position with direct responsibility for QMS processes/sub-processes.

• Sterilization and Microbiology experience in a medical device company beneficial

• External agency inspection experience preferred

• Thorough knowledge of medical device manufacturing equipment, processes & controls.

• Thorough knowledge of 21 CFR 820, ISO13485 with working knowledge of foreign medical device quality system requirements.

• Working knowledge of regulations applicable to the Medical Device Single Audit Program (MDSAP) and applicable sections of the Medical Device Directive and the European Medical Device Regulation.

• Comprehensive understanding of principles and concepts of Manufacturing Excellence, Statistical Process Control and Applied Statistics.  Data driven. Lean or six sigma certification preferred.

• Ability to handle multiple projects simultaneously and to discern major quality issues

• Ability to accurate communicated & record information essential

• Ability to work well under deadlines and pressure

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 - 14 month duration.

Full time hours, hybrid (3 days on-site)

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”.