Quality Assurance (QA) Manager 

The QA Manager will be an integral member of the Plant Leadership Team, tasked with fostering a dynamic Culture of Quality to enhance products, processes, and the Quality Management System (QMS). The role demands strategic leadership in quality assurance, ensuring compliance with industry regulations, and driving continuous improvement initiatives within the organization. 

Key Responsibilities: 

Leadership & Team Development: 

• Oversee the QA department, including direct staff management. 

• Develop and maintain a professional development plan for QA personnel, incorporating goal setting and coaching. 

Quality Strategy & Communication: 

• Formulate and maintain a comprehensive QA strategy, ensuring alignment and communication with key stakeholders. 

QMS Development & Maintenance: 

• Lead the development, implementation, and maintenance of the QMS for all products and processes. 

• Ensure the organization remains audit-ready and compliant with required standards, regulations, and company procedures. 

Quality Oversight: 

• Supervise quality control for raw materials, packaging components, in-process items, and finished products. 

• Manage quality oversight for change control, complaints, internal audits, risk management, and external audits by regulatory bodies. 

• Oversee validation activities related to processes, equipment, and computer systems. 

• Guide the quality aspects of introducing changes to existing products and launching new products. 

Operational Excellence & Process Improvement: 

• Support and lead quality-related initiatives within the site's operational excellence program. 

• Collaborate with manufacturing to maintain and enhance product quality, driving cost-of-quality initiatives. 

QA Technical Direction: 

• Provide technical guidance in QA to help achieve company objectives. 

Budget Management: 

• Prepare and manage the QA operating budget in coordination with the Operations and Finance teams. 

Stakeholder Engagement & Decision-Making: 

• Make key decisions regarding product quality in consultation with relevant stakeholders. 

• Participate in Plant Leadership Meetings and represent the site at Global Quality Leadership Team (QLT) meetings as necessary. 

• Serve as the Management Representative/Authorized Representative/Person Responsible for Regulatory Compliance as required by medical device regulations. 

Additional Duties: 

• Perform other duties as required to support the organization’s goals and objectives. 

Work Experience Requirements: 

• Total Experience: 8-12 years. 

• Specific Experience: Minimum of 5 years in a Quality Leadership role within the Medical Device or Pharmaceutical industry, with experience in managing personnel and Quality Systems. 

Educational Requirements: 

• Required: Bachelor's degree in Quality, Science, Engineering, or a related discipline. 

• Preferred: Advanced degree. 

Specialized Skills/Technical Knowledge: 

• Regulatory Knowledge: 

• Extensive understanding of QMS elements and regulatory requirements (e.g., ISO 13485, ISO 14971, FDA 820.30, MDD/MDR). 

• Experience with internal and external audit management, including representation during interactions with notified bodies and regulatory agencies. 

Technical Skills: 

• Strong working knowledge of continuous improvement and root cause problem-solving in manufacturing settings. 

• Demonstrated project management skills with the ability to execute tasks efficiently. 

Communication & Interpersonal Skills: 

• Ability to communicate effectively at all organizational levels and with external entities such as customers, suppliers, and regulatory bodies. 

• Excellent interpersonal skills, enabling effective teamwork in cross-functional environments. 

Analytical & Problem-Solving Skills: 

• Exceptional analytical abilities, including problem definition, data collection, fact-finding, and timely decision-making. 

Continuous Improvement & Change Management: 

• A mindset geared towards continuous improvement, with proven change management skills. 

 This position demands a leader who is not only technically proficient but also capable of guiding and inspiring a team, driving quality excellence, and ensuring regulatory compliance in a dynamic environment, if this sounds like a challenge you’re up for please apply now as an expression of interest in a discovery call. 

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

 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/   

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. 

 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”