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Job ID: JOB-13524
Quality Team Lead

 HERO are working with a global leader in Medical Device to find the very best of talent for their Cork operation. Why should you apply? This Quality Team Lead job opportunity in Cork offers exceptional career development opportunities whilst delivering excellent salary and benefits package. Let’s talk to see if this is the right move for you.

Purpose

Act as a member of the Cork facility quality team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant

Key Responsibilities

• Supervision of Quality Technicians and Quality Engineers.
• Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
• Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
• Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Approval of change requests for product, process and quality system changes.
• Customer complaints: Approval of analysis reports and analysis of complaint trends.
• Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Perform internal quality audits.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.
• Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities

Key Qualifications

• Requires a minimum level 8 qualification in a relevant Engineering / Science degree.
• Excellent interpersonal and communication skills.
• Ability to work as part of a team and meet targets/goals efficiently.
• Excellent analytical and problem-solving skills.
• Demonstrated decision making skills.
• Minimum of 4+ years’ experience within a manufacturing environment.
• People management experience is advantageous.
• Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.

For further information on this role in Cork please contact Aisling Kidney on 0872197421 or careers@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Mark Wilson

JOB-13524

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