Job Title: Quality Lab Manager (Electro-Mechanical Medical Devices)

Location: Dublin North

Company Overview

Our Client is a leading innovator in the medical device industry, specializing in the design, manufacture, and distribution of high-quality electro-mechanical devices. We are committed to improving patient outcomes by delivering reliable, cutting-edge solutions. As part of our commitment to quality and safety, we are seeking a dedicated and experienced Quality Lab Manager to lead our quality control and testing efforts.

Job Summary

The Quality Lab Manager will oversee all quality assurance and testing activities within the lab, ensuring that electro-mechanical medical devices meet the stringent regulatory and quality standards required in the healthcare industry. The ideal candidate will have strong leadership skills, a solid technical background in electro-mechanical devices, and experience with regulatory compliance (e.g., ISO 13485, FDA regulations).

 

Key Responsibilities

Lab Operations Management:

Manage daily operations of the quality lab, including the scheduling, coordination, and supervision of lab personnel and activities.

Develop and maintain standard operating procedures (SOPs) for testing electro-mechanical devices.

Ensure that lab equipment is properly maintained, calibrated, and validated according to regulatory standards.

 

Testing and Quality Control:

Oversee incoming material, in-process, and final product inspections and testing, ensuring compliance with regulatory requirements and internal quality standards.

Lead validation and verification testing of new and existing products, including functionality, durability, and safety tests.

Analyze test data, generate reports, and provide recommendations for product improvements.

Drive root cause analysis and corrective/preventive actions for any quality issues.

 

Compliance and Audits:

Ensure lab practices adhere to relevant regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and other applicable standards.

Lead internal audits and host external audits from regulatory bodies or clients as required.

Collaborate with Regulatory Affairs to ensure all devices meet applicable global regulatory requirements.

 

Team Leadership and Development:

Manage and mentor a team of lab technicians, ensuring continuous training and development.

Foster a culture of continuous improvement, encouraging proactive problem-solving and quality mindset.

Work cross-functionally with Engineering, Manufacturing, and Quality Assurance teams to resolve issues and improve processes.

 

Documentation and Reporting:

Maintain accurate records of all testing procedures, results, and lab activities, ensuring traceability and compliance with GMP standards.

Prepare quality reports, metrics, and KPIs for senior management.

 

Experience:

5+ years of experience in a quality or testing role within the medical device industry, preferably with electro-mechanical devices.

Proven experience managing a quality or testing lab in a regulated industry (e.g., medical devices, pharmaceuticals).

Strong knowledge of ISO 13485, FDA regulations (21 CFR Part 820), and Good Manufacturing Practices (GMP).

 

Skills:

Experience with electro-mechanical device testing and validation.

Proficiency in quality management systems (QMS), risk management, and root cause analysis techniques.

Strong leadership, communication, and problem-solving skills.

Ability to work cross-functionally and lead quality improvement initiatives.

 

Certifications (Preferred):

Certified Quality Manager (CQM) or Certified Quality Engineer (CQE) from ASQ.

Six Sigma Black Belt or Green Belt certification.

Certification in auditing standards such as ISO 13485 or ISO 9001.

 

Please note, candidates must be eligible to work in Ireland without restriction.

For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

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