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Job ID: JOB-13480

Quality Control Supervisor

Tired of feeling undervalued as a Quality Control Supervisor?

Join this leading company in Galway and you will feel the difference.  Join a growing company who values their people.  Our client is an exceptional company who offer their Quality Control Supervisor top salaries and benefits!  If you’re applying for a mortgage, where salary and benefits are key, this is a must job to explore.  Let’s have a conversation to see if this is right for you.

The position of Quality Control Supervisor requires an experienced and proven candidate with a background in Quality Control, Quality Assurance and Regulatory compliance of Medical Devices.

The successful candidate will work as part of a team to maintain high quality/performance standards across the company.  Reporting to the Senior Manager QA/RA, the position will be challenging and will require an ability to work autonomously.

Responsibility and Authority

Quality Control

• Provide Leadership / Direction and Support to the QC Inspection team including:
• Maintenance of fully compliant documents and procedures
• Management of training/development needs
• Co-ordination of QC inspection schedules aligned to support and deliver Quality /Manufacturing/Design Services -NPI/ Customer deadlines.
• Management of environmental monitoring activities, Endotoxin (LAL) and Product Bioburden sampling program
• Management of QC Inspection record review / release, including final product release
• Complete customer and supplier notification change assessments and appropriate follow on actions
• Co-ordination & Review of Key performance Indicator data for presentation to Management
• Co-ordinate Internal audits of Clean Room (Line audits)

Quality Assurance / Regulatory Compliance

• Collaborate with the Project teams to facilitate the successful execution of the Design Services process and Commercialization of new products.
• Provide expertise in the areas of Quality Assurance, Risk Management, Statistical Techniques, and Regulatory Compliance.
• Lead and Support NPI engineering activities (including but not limited to)
  • New product introductions
  • Development and approval of new product documentation.
  • Qualification of new suppliers/ requalification of existing suppliers
  • Risk management activities
• Provide expertise for new product introduction / product development / process changes with respect to:
  • Acceptance criteria development
  • Test method development/validation activities
  • Product / process validation protocol development and execution (IQ, OQ, PQ)
  • pFMEA, Risk management activities
  • Material / Product testing requirements (e.g. ISO10993)

• Ensure that new medical device product development / new product introduction and changes to existing products are conducted in compliance with global regulations and internal procedures.
• Contribute to process improvement efforts by developing and updating procedures and work instructions.
• Develop and maintain documentation in compliance with ISO and FDA requirements.
• Provide on-going support to manufacturing site(s) for commercially available products
• Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations.
• Initiate / Support implementation of effective Corrective / Preventive Actions
• Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.
• Function as the QA representative for Supplier Quality management activities
• Represent QA as part of the Material Review Board
• Perform Internal and Supplier Audits
• Support Notified Body / Regulatory Agency / Customer Audits
• Collate and trend Key performance indicator data.
• Actively participate in Management Review & Compliance meetings
• Perform additional duties as required by the role and management.

Role Requirements

• Minimum degree in Quality Engineering, Manufacturing engineering, Life science or related field.
• Minimum of 5 yrs. experience at Senior Engineer level within the Medical Device Industry including at least 2yrs. proven People management experience.
• Proven record of handling and delivering multiple tasks simultaneously and ability to manage project timelines.
• Proven record of policy and procedure development
• Can demonstrate understanding and application of quality philosophies, principles, systems, methods, tools, and standards
• Must be highly motivated with excellent communication skills and proven ability to work effectively as part of a team and interact professionally with all organizational levels
• Function as a mentor to less experienced colleagues
• Quality Certification and Lead Auditor Certification is a plus.
• Supplier Quality engineering experience is a plus.
• Sterilization / Microbiology experience is a plus.
• Ability to travel is a requirement

For further information on this role please contact Katie Kilbane on 086 1283368  / network@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.

Katie Kilbane

JOB-13480

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