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Job ID: JOB-13466

Senior Quality Engineer

This is one of those exciting Senior Quality Engineer job opportunities that just stands out from the crowd!  If you’ve been considering a career move then this Senior Quality Engineer role is well worth your time exploring, it will be hard to top on salary package and career growth.

Located in well sought after location of Galway you will be working in a super culture along with a great leadership team who genuinely care about their people’s well-being and career progression. 

Main Tasks:

• Managing key Quality personnel and providing technical support for the manufacture of existing products and support of design and development of new products
• Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality
• Understanding and complying to company’s quality, business, health & safety systems and market/legal regulations and associated Regulatory Standards
• Mitigating against risks associated with the design, use and manufacture of CB’s devices.
• Ensuring their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work. Establish, implement and maintain effective quality management system requirements.
• Reporting to top management on the performance of the quality management system, and ensuring the promotion of awareness of regulatory requirements throughout the organization.
• Ensuring compliance to regulatory requirements appropriate to the quality management system; medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations, including MDR/2017/745, 21CFR820

Responsibilities:

• Ensure NCR/CAPA system is maintained
• Working with other key functions, develop Quality Plans for principle products and product lines.
• Maintain control of nonconforming material and product.
• Develop Inspection Plans and supporting documents that specify inspection and test requirements and sampling levels.
• Interface with other functions in a team environment providing Quality systems input & leadership.
• Provide technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
• Monitor the suitability and effectiveness of the Quality System and assure compliance with current US and international regulations and ISO standards.
• Direct continuous improvement of the system to meet the evolving expectations of customers, business partners and regulators.
• Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance or increase customer satisfaction
• Actively participates in specification development in relation to design input development
• Provide guidance to project teams and engineers in the processing and development of protocols, reports, procedures, deviations and change requests on a day-to-day basis for identified projects
• Develop process validation plans, protocols, risk assessments and reports
• Manage and executes key elements of Production Sterilization, Product Release
• Identify, interpret & manage changes in systems or procedures, which could potentially affect compliance as they relate to assigned projects.
• Ensures internal audits and other activities covered under the company’s Quality Manual, Policies & Procedures are executed.
• Review change control for designated projects for quality assurance implications
• Manage supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions
• Reporting the performance of the quality system and any need for improvement to executive management; and
• Promote awareness of regulatory and customer requirements and Serving as the company’s liaison with customers and other outside concerns on matters related to product quality and reliability.
• Support submission of QMS documents and records
• Maintenance of documentation and records related to the Manufacturer’s QMS (including design history file, manufacturing specifications); or

Requirements:

• Experience in the medical device or other highly regulated branch with experience
• More than 7 years working experience in a quality role in a pharmaceutical/Medical Device environment
• Working experience in a startup is an advantage
• English: Fluent in speaking, good in Reading and Writing
• Knowledge of QMS regulation (ISO 13485 or 9001) Knowledge of risk management
• Extensive knowledge of quality management systems and current international and European regulations/standards with respect to medical devices.
• Design for Manufacturing and lean manufacturing experience is a plus.

For further information on this role please contact Katie Kilbane on 086 1283368  / network@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Katie Kilbane

JOB-13466

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