Company: Tandem Project Management
Location: Waterford, Waterford

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Summary:
My client is now looking to expand their team with the addition of a Quality Assurance Manager. Join a well known company with great culture on site! In this role you will work closely with Engineering and Quality department to manage the quality team and quality systems. The Successful candidates will have a strong Quality Engineering background gained in high-volume & regulated environment. In this role, you will ensure that the product or service of the organization is fit for purpose, consistent and meets both external and internal requirements. Area’s of importance include regulatory compliance, legal compliance and customer expectations.

Responsibilities:

  • Remain up to date with ISO requirements and ensure company is audit ready.
  • Plan and monitor internal audit schedule.
  • Quality system development, implementation & maintenance.
  • Ensuring that processes meet with ISO and AS requirements.
  • Assessing product specifications and customer requirements and ensuring they are met.
  • Agreeing in-house standards for quality.
  • Monitoring performance by gathering data and producing reports.
  • Supervising the programme of internal auditing and calibration.
  • Development, Maintenance and Approval of Standards.
  • Managing quality issues to ensure timely and effective corrective actions to prevent re-occurrence.
  • Providing support to Regulatory and Customer audits.
  • Monitoring the ongoing performance and outputs of the quality process and providing updates to managers and directors around quality issues.
  • Supplier and Customer Liaison on Quality Issues.
  • Provide validation expertise to maintain validated status for the facility.
  • Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, software and process, and approve validation documentation.
  • Maintain an understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment.
  • Coordinate validation activities to ensure schedule adherence and compliance.
  • Using statistical analysis, measure, control and improve on product and process robustness.
  • Maintain a positive department attitude and ensure that all employees under your supervision are aligned with the company goals.
  • Proactively, through the use of team meetings and other communication skills, develop sustainable goals and targets for each team within the area.
  • Lead and develop team.
  • Conduct Performance reviews, RTW, probation reviews etc.
  • Hire/interview as needed. (Operation manager to have input).
  • Discipline as required in line with current procedures.
  • Design, maintain and implement training programmes as agreed with management.
  • Manage holiday schedule.
  • Housekeeping –Maintain Standards.
  • HR Policy -Know and administer HR Policy.
  • Health and Safety – Be pro-active in identifying and addressing any Health and safety issues that arise.
  • Liaise with other departments/sites in Company.

Qualifications & Experience:

  • Degree Qualified in Scientific/Engineering or other technical discipline.
  • 10 + quality (Quality Engineering or QA) experience in manufacturing.
  • Experience in subcontract manufacturing with numerous product lines.
  • Experience in Quality management, including quality systems management.
  • Experience leading and developing teams.
  • Experience with FDA regulations desirable.
  • Ability to introduce and embed new systems successfully.
  • Strong understanding of ISO 13485.