Senior QA Engineer (NEW)

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 Engineer to 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:

• Lead and manage root cause investigations, ensuring timely and effective NCR and  CAPA implementation.

• Assist the QA Manager with the  day-to-day QMS management, ensuring compliance with ISO 13485 and all relevant regulatory requirements.

• Conduct and support internal audits, driving ongoing compliance and quality improvements.

• Support and oversee validation activities, including process validations, test method validations, and risk assessments.

• Provide hands-on quality support for manufacturing, ensuring product compliance and process control.

• Develop, implement, and maintain SOPs and work instructions to drive quality initiatives and support operations.

• Act as a key contact for customer quality concerns, complaints, and regulatory inquiries, leading investigations where required.

• Identify and lead continuous improvement projects to enhance efficiency and product quality.

• Mentor and support junior quality team members, contributing to a culture of learning and professional growth.

• Assist in supplier quality management, ensuring robust quality agreements and ongoing compliance.

• Own and manage the PM/Calibration schedule.

• Assist with the development of other quality personnel as required.

• A Bachelor’s degree in Engineering, Quality, Life Sciences, or a related discipline

• 5+ years’ experience in a medical device or regulated manufacturing environment

• Proven experience with root cause analysis, CAPA management, and failure investigations

• Training in ISO 13485 internal auditing (lead auditor certification preferred but not essential)

• Strong understanding of quality engineering tools and principles such as FMEA, SPC, risk management, and validation

• Excellent analytical and problem-solving skills, with a data-driven mindset

• Effective communication and interpersonal abilities, with a collaborative approach

• Proficiency in Microsoft Office Suite and quality management software

  Why Apply ?

• An opportunity to step up to senior-level responsibilities

• A forward-thinking, collaborative environment that encourages creativity, autonomy, and professional growth

• Direct influence on product quality, process improvements, and team development

• Join a company making a real difference in patients’ lives through high-quality medical device technology.

This is a fantastic opportunity to join a forward-thinking team and thrive in a collaborative, supportive environment that values creativity and teamwork!

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

-Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce-