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Quality Manager

Quality & Laboratory
Offaly
Therese Keohane
Permanent
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Job Reference: JO-2101-65525_1609947465

Summary:


Permanent Quality Manager required to provide oversight to the manufacture of a diverse portfolio of products with our Offaly based client.


Key Responsibilities:



  • Ensure department KPI's and objectives are met - safety, quality, complaint analysis, product conformances.

  • Ensure achievement of recognised quality standards (ISO13485 & 22416) and legal compliance.

  • Site lead for Notified Body and customer audits.

  • Approval of Technical Transfers and Quality Agreements.

  • Audit contractors and suppliers etc. to ensure they comply with site standards.

  • Provide advice and support to sales/ technical personnel and other stakeholders.

  • Monitor quality data daily, and take appropriate action, make decisions, or highlight when necessary.

  • Lead all elements of Quality Control, document control, validation, calibrations, customer Quality interface and supplier Quality assurance by developing key supplier partnerships

  • Develop and deliver excellence in manufacturing practices and work with team to develop engagement of all employees in the improvement of Quality, creating training and quality standards to enhance and ensure competence.

  • Management of the Quality Department including annual goal setting, multiskilling, training and management of Quality standards.

  • Any other duty assigned within the skill of the employee.



Essential Criteria:



  • Requires a Bachelor's degree in Quality / Science / Engineering or other Technical field

  • 10 years of manufacturing experience working in a quality assurance role or related department desired. 5-7 years, people management experience.

  • Must have an understanding of common problem-solving tools such as statistical analysis, DOE, Pareto charts and histograms.

  • Experience in Lean Six Sigma with certification required.

  • Audit qualification or experience.



Desirable:



  • Strong leadership and change management skills.

  • Candidates from a Medical Device background with FDA/ISO or have substantial experience with ISO 13485 & 22416 will have an advantage.

  • Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions. Proficient at multitasking and prioritizing.

  • Thorough knowledge and understanding of manufacturing systems and solid working knowledge of processes and products.

  • Excellent communication skills - written, verbal and interpersonal.

  • Projects a strong professional image and able to interact within all levels of the organization.

  • Well versed in statistics, detail oriented



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Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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