Medical Device Compliance jobs

This role is located in Galway, Ireland.

Opportunity – Senior Quality Assurance Engineer
InVera Medical, a clinical-stage CE Marked medical device manufacturer, seeks an innovative Quality Assurance professional. The successful candidate will be an active member of the QA/RA team building innovative minimally invasive devices designed specifically for sufferers of chronic venous disease. The role will span the full product lifecycle from concept ideation to regulatory approval and treatment of patients worldwide. The role is based at our offices in the ATU iHub Galway City.

Role responsibilities

• Development, implementation and continuous improvement of an efficient, work-flow based and fully compliant quality management system in accordance with ISO 13485, and 21 CFR Parts 808, 812, 820 to meet the requirements of all stakeholders.
• Planning, implementation and coordination of quality assurance to include quality specifications, processes, training, CAPA, validation & verification procedure documentation, and material safety specifications.
• Coordinate and support execution of supplier assessment, selection and qualification activities.
• Support internal and external audit activities.
• Review and revise Quality Management System documentation to keep current with industry standards.
• Apply knowledge of design control and risk management principles and quality engineering techniques throughout the product development process.
• Support quality-related activities for device manufacturing ensuring controls are implemented and maintained (inspection standards, plans, frequencies, and test methods).
• Preparation and maintenance of documentation in compliance with appropriate regulatory requirements.
• Contributes to Design Verification and Validation Strategies with functional partners (R&D, Manufacturing and Regulatory Affairs) to ensure an efficient regulatory submission approval path.
• Understand and apply Risk Management concepts used to ensure Product Safety requirements in accordance with EN ISO 14971.
• Generation of risk management file documents; Risk Management Plan, Hazard Analysis, Design FMEA, Process FMEA, Risk Management Report.
• Manage and maintain the records related to design control and risk management activities in accordance with QMS requirements.
• Support development of test methods for product evaluation, verification, and validation, including test quantity calculations based on confidence and reliability intervals and risk-benefit analysis.

Requirements

• Bachelor’s degree in science, engineering, or a related field.
• Minimum 5 years of quality assurance experience for a Class II medical device.
• Excellent understanding of Quality Systems with a proven track record of running, implementing or improving Quality System Processes.
• ISO 13485 Lead Auditor Training is desirable.
• Experience of working as an agile member of the R&D quality team across GMP, process validation, change control, CAPA, Auditing, and Risk Management (including FMEA) and electronic document control systems.
• Ability to interpret policies, regulatory and/or governmental regulations, and internal regulations to assure compliance to design control, risk management and Quality Management System elements.
• Ability to apply systematic problem-solving methodologies in identifying, prioritizing, presenting, and resolving quality issues.
• Experience of preparing technical documentation.
• Excellent verbal and written English communication and collaboration skills.
• Strong organisational skills and attention to detail. Results-orientated and quality-focused.
• Ability and willingness to inspire, lead and effectively work as part of a small team.
• Prove previous results-focused work practices with honest self-evaluation of progress towards defined objectives.
• Ability to thrive in a start-up environment, or in absence of previous start-up experience, willingness to adapt to a small company environment.
• Desire to learn new skills and achieve personal development in medical device industry fields.
• Ability to prioritise and manage busy workload encompassing several active projects, and the work load of the project team to achieve project deliverables, highly organised.
• Values honesty and transparency to identify and resolve issues.

About
InVera Medical is developing Class II medical devices for the office-based treatment of chronic venous disease (CVD), a condition which affects one in four adults causing a range of disease symptoms from varicose veins to venous leg ulcers. This novel device enables a less invasive and highly effective option offering a significant improvement over existing thermal, and non-thermal technologies. InVera’s first product is a mechanical endovenous infusion catheter that enables precise and efficient delivery of physician-specified agents in superficial veins in a single-use, disposable catheter-based solution significantly improving the quality of life for millions of sufferers across the globe. Future minimally invasive product lines will form the basis of a rich endovascular device innovation portfolio.

Job Types: Full-time, Permanent

Benefits:

• Company pension
• Flexitime
• Sick pay

Ability to commute/relocate:

• Galway, County Galway: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor's (required)

Experience:

• Medical Device Quality Assurance: 5 years (required)

Work authorisation:

• Ireland (required)

Work Location: Hybrid remote in Galway City, County Galway