Senior Product Quality Specialist

2 weeks ago

Cork, Cork, Ireland beBeeAssurance Full time €60,000 - €80,000

Quality Assurance Lead

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In this role, you will be responsible for ensuring the quality of products throughout all phases of development and commercialization. You will oversee the implementation of quality management systems and ensure effective communication with stakeholders.

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You will investigate complaints and nonconformances, drive corrective actions, and verify their effectiveness. Additionally, you will guide and support other quality team members in their roles.

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This position requires a seasoned professional with a full working knowledge of EN ISO 13485 and the principles of GMP and FDA QSR 21 CFR Part 820. A degree in an engineering or quality-related discipline is also required.

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Certification as a Quality Engineer is desirable. Proficiency in statistical analysis, process validations, FMEA's, and protocols is essential. Structured problem-solving techniques, Lean Six Sigma Green Belt, and understanding of Lean Principles are also beneficial.

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This role involves working in a fluid, demanding environment. You must have an understanding and appreciation of Teleflex's ethics standards and the ability to gain technical understanding of processes and products.

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Travel is required up to 10% of the time. The work environment is primarily office-based.

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Key Responsibilities:

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  • Implement quality management systems and procedures
  • Investigate complaints and nonconformances
  • Drive corrective actions and verify their effectiveness
  • Guide and support other quality team members
  • Develop and implement programs to ensure compliance with regulatory requirements
  • Provide support for internal, customer, and regulatory audits
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Education / Experience Requirements:

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  • Seasoned professional with a full working knowledge of EN ISO 13485 and the principles of GMP and FDA QSR 21 CFR Part 820
  • Degree in an engineering or quality-related discipline
  • Certified Quality Engineer desirable
  • Proficiency in statistical analysis, process validations, FMEA's, and protocols
  • Structured problem-solving techniques - Lean Six Sigma Green Belt desirable
  • Understanding of Lean Principles
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Specialized Skills / Other Requirements:

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  • Ability to work in a fluid, demanding environment
  • Understanding and appreciation of Teleflex's ethics standards
  • Ability to gain technical understanding of processes and products
  • Ability to understand customer/vendor relationships
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Working Environment:

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Office

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Equal Employment Opportunity:

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Teleflex is an equal opportunity employer.

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