Senior Quality Engineer

Natus Medical

Gort, Co Galway
Permanent
Full-time

18 days ago

If you are looking for a challenging opportunity to work in an international environment, then we may have a job for you. We are looking for a self-starter and enthusiastic Senior Quality Engineer to join our Global Quality Assurance team for a 12 month contract.Location: Gort, Co. Galway. This role can be hybrid (3 days onsite)Welcome to Natus Medical Incorporated:We’re the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Our Irish base in Gort, Co. Galway, manufacture and distribute a range of medical device products used in the diagnosis of human neurological disorders.Job Overview:The Senior Quality Engineer is a vital role aboard our Quality Assurance team to help drive process improvement initiatives and streamlining efforts of quality management systems. You can expect to be hands on supporting product development teams with design transfer activities, managing, and closing out CAPAs, and ensuring quality compliance for a diverse product portfolio.Essential Duties & Responsibilities:

Support of Clean Room (Class 8) procedures and controls and Environmental Monitoring
Co-ordination of Sterilisation programme for sterile products (including Dose audit program)
Provides support to product development and sustaining teams including but not limited to design input/output, verification/validation, risk management, and design transfer activities
Drives streamlining improvement initiatives in the Quality Management system across the site
Ensures quality system compliance to ISO13485, 21CFR 820, MDSAP and Medical Device Regulations
Prepares metrics in support of trending and management reviews
Provides quality inputs in product design updates and support design maintenance releases
Conducts internal audits when needed and serves as Quality System support for Regulatory and Corporate Audits
Takes ownership of managing and closing out CAPAs where required.
Guides product transfer activities and streamlining of quality management systems
Stays up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers

Education and/or Experience:

Requirement: Third level degree in science e.g. Biopharmaceutical Science /Microbiology/ Chemistry or similar
4-6 years of experience in Microbiology or Quality Assurance in the medical device industry, including experience with design controls and design transfer activities
Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
Strong CAPA experience
Experience of sterile products in a medical device or pharmaceuticals
Demonstrated excellent organizational skills and ability to work on own initiative essential.
Excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken

Here’s what you can expect:

Attractive Salary package
Hybrid flexible working
Defined Contribution Pension plan
Health Insurance

Free Parking

EEO StatementNatus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.#LI-LM1 #INDNATUS #HYBRIDJOBS #REMOTEJOB #QUALITYJOBS #GALWAY #CLARE

Natus Medical

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