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-
All done
Your application has been successfully submitted
Other jobs