Quality Manager - County Longford.

Quality Manager - County Longford.

Job Description
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.

• Formulate a strategy to foster a high performance culture with quality right first time suitable for a world-class medical device 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.
o Plan and strategise for systems and procedure evolution commensurate with growth plans and identify for future requirements.
• Drive improvements to the quality system that ensure 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 long-term 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. Determine 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.

Interested applicants should have:

• Bachelor’s degree in Engineering or scientific related field.
• A minimum of 4 years' experience in the medical device or pharmaceutical industry, with at least 3 years' experience in regulatory compliance and quality systems.
• At least 4 years' experience in managing a team
• Thorough knowledge of ISO 13485 and 21CFR Part 820.
• Ideally 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.