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Start Up Quality Manager

  • Sector: Medical Devices
  • Contact Email: christopher.otoole@collinsmcnicholas.ie
  • Job Ref: 18039

Our client, a high potential and heavily funded start up are looking to hire a Quality and Regulatory Manager who will lead the Quality activities to bring a novel fluid drainage technology through design development, verification, clinical trials, validation and regulatory approval. This role will provide Quality leadership to meet objectives in the development, implementation and maintenance of a robust and fully compliant Quality System. This position offers the opportunity to join the management team in an exciting early-stage company and to contribute to broader activities outside of quality to achieve company goals.

 

Key Responsibilities and Duties

 

•  Develop, implement and maintain a robust and fully compliant Quality System in accordance with ISO 13485, including risk management.

•  Continuously improve the QMS to meet the requirements of all stakeholders, ensuring processes are lean, compliant, user-friendly and are well understood throughout the organisation.

•  Manage the Quality System audit processes, including supplier evaluations and audits.

•  Provide training to company employees in relevant areas of the Quality System.

•  Manage all Quality-related activities for device manufacturing ensuring effective and efficient controls are implemented and maintained (inspection standards, plans, frequencies, and test methods).

•  Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.

•  Determine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documents.

•  Support product verification and validation, including risk management, biocompatibility testing, pre-clinical and clinical evaluations.

•  Ensure activities are conducted in compliance with the regulations and standards applicable to the product.

•  Manage quality control activities related to production including incoming inspections, audits, process validations.

•  Responsible for device history record review and product release.

•  Manage and effectively communicate with external vendors/partners and regulators as necessary to support Quality activities.

•  Strong project management skills to lead cross functional projects, ensuring on time and on budget delivery.

•  Demonstrate collaborative leadership, being able to collaborate across multiple functions, beyond Quality.

•  Create a strong team working environment with focus on compliance, product quality, and risk mitigation.

 

The above list does not represent an exhaustive list of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may vary or change periodically, and there may be an expectation to contribute to regulatory, preclinical and clinical related areas, in which support and guidance from the broader team will be provided.


Education and Experience

 

•  Minimum Bachelor’s degree in science, engineering, or related field

•  Minimum of eight (8) years in a similar role in medical device quality systems

•  Ideally, experience in Quality/Design Assurance and Regulatory Affairs roles

•  Experience in design, verification, and process validation processes

•  Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems.

•  Deep understanding of ISO 13485 requirements, with the ability to interpret these requirements and implement them into a lean compliant product.

•  Previous communication with responsible regulatory authorities (national/international) as well as with notified bodies.

•  Ideally, a track record of success with FDA 510k submissions and CE mark filings.

•  Desired experience in class II and above medical devices.

•  Experience working with sub-contract manufacturers/suppliers, including integration of quality management systems.

•  Good leadership and project management skills with experience in people management and development.

•  Strong verbal and written communication skills

•  Ideally, demonstrate an ability in selecting, interviewing, training, and directing people in a growing team.

•  Desire to work in a start-up environment where there is a requirement to be flexible and ability to deliver in relatively low-structured environments.

 

For a more detailed and confidential discussion on this opportunity please contact Christopher O Toole.

christopher.otoole@collinsmcnicholas.ie

091 706 713