Senior Design Assurance Engineer - Sustaining - Galway

Senior Design Assurance Engineer, Class IIB & III, rapidly expanding Medical Device company, Galway City

My partner is an international medical device company who has just recently launched their innovative medical device in the United States to great success. They are seeking to follow up the fantastic launch with more products in the New Year as a result of the talented R&D teams and planned mergers. On that basis, we need a Senior Design Assurance Professional to join the team to primarily support new development projects to introduce or improve products for the treatment of a range of diseases.

The focus is on sustaining activities but as the team is relatively small, someone interested in keeping busy and having a broad range of responsibilities will thrive here.

This isn't a monster multinational where you have lots of red tape and slow cross departmental communication. Communication will be fast - enabling you to do your job with as minimal bureaucratic nonsense as possible. A competitive salary package is on offer here paired with working flexibility. As the company is set to explode in 2021, it's a really great time to join and forge your path within the company with strong professional development opportunities along-side the company growth.

What will you do?

• Work within the quality system to ensure that quality policy and company systems are complied with relevant regulations
• Support the development of the company's Design Control, Risk Management, and relevant systems to encompass sustaining activities
• Lead the design verification and design validation assessment of design changes
• Lead the risk management activities for designated sustaining projects, design changes, complaints and CAPAs

What do you need?

• Minimum of 6 years relevant quality/design assurance experience for the Medical Devices industry (class IIB and III preferred)
• Technical competency in the following:
• ISO13485:2016
• ISO 14971
• FDA QSRs
• Experience with statistics, validation and physical testing is ideal
• Strong communication and organizational skills enabling you to present reports to relevant stakeholders

For more information please send a recent copy of your CV on a MS Word document to Blaine McKeever or call using the details listed and the ext. 3505. Successful candidates will be contacted immediately, and presented with current vacancies.

Not quite the right position for you? Do you know of someone who this could be more suited for? NonStop offers a referral fee for every candidate successfully placed so please do share this advertisement on with anyone who could be interested in positions in the Ireland.

Nonstop Recruitment is a recruitment consultancy with fully licensed and staffed offices across Europe. We are renowned for professionalism, unrivalled industry knowledge and extensive candidate networks.The service our multinational, multilingual teams provide is underpinned by an in-house Quality Assurance team, something unique in our industry. Contact us for more opportunities.