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Senior QA Engineer (NEW)

  • On-site
    • Wicklow, Ireland
  • Quality Assurance

Job description

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.

Job requirements

  • 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-

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