Direct message the job poster from HERO Recruitment
Principal Recruitment Consultant - Contact STEM@hero.ie or call 0868395533
Job Title: Senior Quality Systems Engineer
Location: County Westmeath, Ireland
Company Overview:
Our client, a leading medical device manufacturer in County Westmeath, is seeking a Senior Quality Systems Engineer to join their innovative and dynamic team. This is an exciting opportunity for an experienced professional to drive quality improvements and ensure compliance with industry standards in a fast-paced, regulated environment. If you are passionate about quality systems and looking to make a significant impact, this could be the perfect role for you.
The successful candidate will need to be strong on Software/Systems Validation not programming or coding, but validating software applications, you must be able to demonstrate how you go about validation, writing the test scripts and executing.
Key Responsibilities:
* Quality Representation: Act as the key representative for the Quality function in site management meetings, supporting the Quality Lead in all quality-related matters.
* Software Validation Leadership: Lead the software validation process, ensuring all validation activities are compliant with industry regulations and standards.
* Process Improvement: Drive significant process improvements, using data analysis and quality tools to implement cost-saving initiatives and enhance overall quality.
* Project Leadership: Lead and manage projects, overseeing resource allocation, risk documentation, process validation, and test methods, ensuring successful project delivery.
* CAPA & NC Investigations: Lead investigations into Corrective and Preventive Actions (CAPAs) and Non-Conformance (NC), ensuring compliance issues are addressed effectively.
* Auditing: Perform internal and supplier audits, and facilitate external audits from regulatory bodies such as ISO and FDA.
* Cross-functional Collaboration: Provide expert guidance to cross-functional teams, including Quality and Engineering, to implement robust solutions and ensure compliance with standards.
Key Skills & Experience:
* Educational Requirements: Bachelor’s Degree or higher in Engineering or a Science-related field (minimum Level 8 qualification).
* Experience: Minimum of 5 years in regulated environments, preferably within the medical device sector, with a strong understanding of FDA or ISO 13485 standards.
* Certifications: Lead Auditor or Internal Auditor certification is desirable.
* Software Knowledge: Experience with software lifecycle tools such as JIRA, Qtest, and VERA is advantageous. Knowledge of Oracle, FactoryTalk, PEMAC, and Bartender will be beneficial.
* Personal Qualities: Strong leadership and communication skills with the ability to lead investigations, audits, and process improvements in complex environments.
Why Join Our Client?
* Impactful Role: Play a critical part in improving the quality of life for medical device users through impactful projects.
* Career Growth: Work for a company committed to your professional development, offering clear career progression and continuous learning opportunities.
* Collaborative Environment: Join a team of passionate, innovative professionals working together to achieve excellence in quality systems.
Quality of Life in County Westmeath, Ireland:
County Westmeath offers a great balance of rural charm and modern amenities, with beautiful landscapes, vibrant communities, and excellent schools, providing a high quality of life for individuals and families alike.
Apply Today! If you're ready to take on a challenging and rewarding role, apply now to join a leading company in County Westmeath.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
* Medical Equipment Manufacturing
#J-18808-Ljbffr