Quality Manager

Our Client, an expanding Medical Device Manufacturer located in Longford and seeking a Quality Manager to join their team on a permanent basis and take ownership if the Quality Department.

This is an exciting opportunity to lead a Quality team that has doubled in since last year due to our Client’s ongoing expansion of both the site and product portfolio. Our Client is interested in meeting Senior Quality Engineers with people management experience or current managers who wants to progress into a Senior Management team.

Job Purpose:

You will manage the quality function by providing work direction for quality engineers and inspectors and interact regularly with engineering, manufacturing and service functions to establish quality standards for raw material, work in process and finished products.

Key Responsibilities:

• Formulate a strategy to foster a high performance culture with quality right first time suitable for a world class medical device contract and legal manufacturer.  
• Lead and motivate a large team with strong quality assurance, quality control, stakeholder partnership, risk assessment and mitigation. 
• Benchmark and implement best practice.  Foster programs around best practice, risk mitigation, proactive problem solving, innovation, clear autonomy, delegation  and clear responsibility with structures fit for purpose, individual and team development and  succession planning.
• Plan and strategise for systems and procedure evolution commensurate with growth plans and identify for future requirements.
• Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
• Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Work closely with commercial and operations to build value with top 10 key accounts and engage with customer quality representatives directly. Implement strategies and tactics to drive short, medium and longterm innovation and improvement plans in the relentless pursuit of zero defects. 
• Provide operational support related to defining accurate problem statements, issue resolution and problem solving, product quality/risk assessment, and product disposition.
• Assist in the investigation of non-conformances as required.
• Conduct, coordinate and review investigation of product complaints and assignment of root cause determinations when required. Determines if complaints require regulatory affairs involvement for adverse event evaluation.
• Provide QA support in the review and approval of plant related validation protocols, reports, and change requests.  Support Project Management Office in timely pursuit of progression of priority activities.
• Provide facility quality support and representation in new product development, scale up, design transfer, and facility validation activities.
• Represent quality and/or regulatory on core design change and new product development teams to ensure the design control process is followed effectively.
• Participate in the ISO 13485 certification process and regulatory inspection.
• Provide support in customer, supplier, and regulatory audits.
• Maintain quality systems and provide support for specific sections of the quality system as assigned.
• Develop and conduct training related to quality system and regulatory requirements.
• Develop quality SOPs to ensure compliance.
• Adopt key enablers such as best practice, automation and ICT platforms that drive efficiency and improvements.

Key Requirements:

• Bachelor’s degree in Engineering or scientific related field.
• A minimum of 5  years of experience in the medical device or pharmaceutical industry.
• At least 4 years of experience in managing a team
• Thorough knowledge of ISO 13485 and 21CFR Part 820.
• Experience handling multiple responsibilities with minimal direction.
• Strong written and verbal communication skills; strong presentation skills.
• Able to effectively work with various functions and levels within the organization.

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

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