Product Compliance Manager

3 days ago

Athlone, County Westmeath, Ireland beBeeCompliance Full time €53,000 - €65,500

Job Title: Quality Assurance Specialist

Purpose of the Role:

The Quality Assurance Specialist plays a vital part in ensuring product quality, regulatory compliance, and continuous improvement within a regulated environment.

Key Responsibilities:

  • Initiate and complete technical and cost-saving activities for process improvements including risk documentation, test methods, process/software validation, and procedural updates.
  • Review, approve change controls, and ensure compliance with established procedures.
  • Perform statistical analysis and interpret data using appropriate statistical tools and methods.
  • Develop and implement effective sampling strategies to meet regulatory requirements.
  • Write and review Corrective Action Requests (CARs), Non-Conformance Reports (NCRs), and Supplier Corrective Action Requests (SCARs).
  • Ensure ongoing compliance in Product Manufacturing, Packaging, and Labeling.
  • Conduct internal and supplier audits to verify compliance with regulatory standards.
  • Support and participate in external audits by regulatory bodies, such as ISO and FDA.
  • Collect, compile, and analyze Quality Metrics and other performance data to inform business decisions.
  • Maintain training records and associated documentation, and follow Environmental, Health, and Safety (EHS) policies and procedures.
  • Collaborate with cross-functional teams to drive continuous improvement initiatives across the business.

Required Experience:

Minimum 3 years' experience in a regulated environment, preferably within the medical device sector or an FDA/ISO 13485 certified environment.

Required Skills:

Strong attention to detail, strong computer proficiency, familiarity with statistical tools, experience with risk management tools, strong problem-solving skills, clear and effective communication skills, ability to work in a fast-paced team-oriented environment, experience in change control implementation, and demonstrated adherence to CGMP and compliance standards.

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