Senior QA Engineer (NEW)

Pale Blue Dot Recruitment; Wicklow; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading medical device company located in Bray, Wicklow is seeking a Senior Quality Assurance Engineer. This role offers the opportunity to drive quality excellence and mentor team members in a collaborative environment. Candidates should have over 5 years of experience in a regulated manufacturing environment and a degree in a relevant field. Responsibilities include managing quality investigations and compliance with ISO 13485 standards, contributing to impactful quality initiatives.

Benefits

Career progression

Collaborative environment

Direct influence on product quality

Qualifications

• 5+ years’ experience in a medical device or regulated manufacturing environment.
• Proven experience with root cause analysis and CAPA management.
• Training in ISO 13485 internal auditing preferred.

Responsibilities

• Lead and manage root cause investigations.
• Assist the QA Manager with day-to-day QMS management.
• Conduct and support internal audits.
• Support validation activities including process validations.
• Provide hands-on quality support for manufacturing.
• Mentor junior quality team members.

Skills

Root cause analysis

CAPA management

Problem-solving skills

Effective communication

Education

Bachelor's degree in Engineering, Quality, Life Sciences

Tools

Microsoft Office Suite

Quality management software

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.