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 Wicklowis currently seeking a skilled and motivatedSenior Quality Assurance Engineerto join their team. Are you a quality professional whos 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 Bachelors 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-