Senior Quality Manager Hybrid

We are delighted to bring another senior opportunity to the midlands market. Our client is seeking to recruit a Senior Quality Manager with managerial & leadership capabilities to manage a Quality division. This position will be based at their manufacturing medical device facility in Co. Longford. This position will require you to be full time on site for the first 6 months after which time the position will be Hybrid with the option of 1-2 days working remotely.

• Lead and motivate a team which includes 4 Director reports Quality Engineers along with a wider Quality team total team size 29 within the Quality function.
• Manage a strategy to foster a high performance culture with quality right first time suitable for a world class medical device contract and legal manufacturer.
• Implement best practice and foster programs around best practice, risk mitigation, proactive problem solving, innovation, clear autonomy,
• Manage team development and succession planning.
• Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
• Ensure the compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Oversee 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.
• Participate in the ISO 13485 certification process and regulatory inspection.
• 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.

• Bachelor’s degree in Science or Engineering or Scientific related field.
• A minimum of 5-10 years of experience in the medical device or pharmaceutical industry with at least 3 years of experience in regulatory compliance and quality systems.
• At least 4 years of experience in managing a team
• Thorough knowledge of ISO 13485 and 21CFR Part 820.
• Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) and/or Certified Manager of Quality/Operational Excellence (CMQ/OE).
• 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.

• Benefits Package Healthcare & Pension
• Bonus
• Hybrid after 6 months
• Workplace Flexibility  
• Competitive total rewards