Exclusivity: This position is being managed exclusively by Pale Blue Dot Recruitment on behalf of our client. All applications and enquiries will be managed directly through ourselves.
Are you a driven and experienced Quality Engineer looking for your next big opportunity?
A leading medical device company based in Bray, Wicklow is currently seeking a skilled and motivated Senior Quality Assurance Engineerto join their team. Are you a quality professional who’s ready to take on increased responsibility, mentor others, and drive excellence in a high-performing, regulated environment? This opportunity offers real career progression, exposure to a wide range of quality systems and activities, and the chance to make a meaningful impact in a company that values continuous improvement, innovation, and teamwork.
Responsibilities include but are not limited to:
1. Lead and manage root cause investigations, ensuring timely and effective NCR and CAPA implementation.
2. Assist the QA Manager with the day-to-day QMS management, ensuring compliance with ISO 13485 and all relevant regulatory requirements.
3. Conduct and support internal audits, driving ongoing compliance and quality improvements.
4. Support and oversee validation activities, including process validations, test method validations, and risk assessments.
5. Provide hands-on quality support for manufacturing, ensuring product compliance and process control.
6. Develop, implement, and maintain SOPs and work instructions to drive quality initiatives and support operations.
7. Act as a key contact for customer quality concerns, complaints, and regulatory inquiries, leading investigations where required.
8. Identify and lead continuous improvement projects to enhance efficiency and product quality.
9. Mentor and support junior quality team members, contributing to a culture of learning and professional growth.
10. Assist in supplier quality management, ensuring robust quality agreements and ongoing compliance.
11. Own and manage the PM/Calibration schedule.
12. Assist with the development of other quality personnel as required.
The duplicated list items and some formatting issues have been corrected for clarity and conciseness. The description now focuses on key responsibilities without repetition, maintaining the professionalism and detail necessary for attracting suitable candidates.
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