Job Description
Quality Manager - County Longford
About the Role
As a Quality Manager, you will be responsible for managing the quality function by providing work direction for quality engineers and inspectors.
You will interact regularly with engineering, manufacturing, and service functions to establish quality standards for raw materials, work-in-process, and finished products.
Main Responsibilities:
* 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.
* 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.
* Provide operational support related to defining accurate problem statements, issue resolution, and problem solving, product quality/risk assessment, and product disposition.
Requirements
We are looking for a candidate with:
* 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.
* Ideal certifications include Certified Quality Engineer (CQE), 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.