Direct message the job poster from Pale Blue Dot Recruitment Limited
Pale Blue Dot Recruitment | The Experts in MedTech Recruitment
Are you a driven and experienced Quality Engineer looking for your next big opportunity?
A leading medical device company based in Wicklow is currently seeking a skilled and motivated Quality Assurance Engineer II to join their team. This is more than just a job — it’s a launchpad into a Senior QA role, ideal for 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 CAPA implementation.
2. Take ownership of 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.
Requirements:
1. A Bachelor’s degree in Engineering, Quality, Life Sciences, or a related discipline
2. 3+ years’ experience in a medical device or regulated manufacturing environment
3. Proven experience with root cause analysis, CAPA management, and failure investigations
4. Training in ISO 13485 internal auditing (lead auditor certification preferred but not essential)
5. Strong understanding of quality engineering tools and principles such as FMEA, SPC, risk management, and validation
6. Excellent analytical and problem-solving skills, with a data-driven mindset
7. Effective communication and interpersonal abilities, with a collaborative approach
8. Proficiency in Microsoft Office Suite and quality management software
Why Apply?
1. An opportunity to step up to senior-level responsibilities
2. A forward-thinking, collaborative environment that encourages creativity, autonomy, and professional growth
3. Direct influence on product quality, process improvements, and team development
4. Join a company making a real difference in patients’ lives through high-quality medical technology
-Pale Blue Dot Recruitment – The Resource for the MedTech Workforce-
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance, Engineering, and Project Management
Industries
Medical Equipment Manufacturing and Manufacturing
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