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Quality Supervisor

  • Location: County Westmeath
  • Job Type:Permanent
  • Sector: Medical Devices
  • Contact: Mary Mullin
  • Contact Email: mary.mullin@collinsmcnicholas.ie
  • Job Ref: 17823

Quality Supervisor - Permanent role - Midlands


Role Summary:

Reporting to the Quality Manager you will be responsible to proactively support the operational activities with regards to the Quality Management System including:

· management of the quality inspector team ensuring alignment with daily operations requirements to fulfill customer orders and incoming receipt area to complete on-time delivery inspection requirements.

· Management of compliance-related sub-systems including non-conformance management and management of the internal calibration system.

·       Lead the development of the QMS process to streamline QA inspection.

·       Ensuring compliance to internal acceptance criteria and relevant global standards and regulations.

·       Co-ordination with various engineering teams to provide support to product development and investigations.


This is an essential function in the overall strategy for improved Quality assurance of delivered product quality and improvement of the established QMS to support the growth of the Company.

 

Main Duties and Responsibilities include:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

 

·       Management of the QA Inspector team to support the delivery of key objectives.

·       Maintain a close professional working relationship with internal and external teams.

·       Work with the Operations, Material, and Engineering teams to coordinate activities.

·       Working in conjunction with Engineering Departments, co-develop design verification & validation protocols for new products (or transfer) and for change on existing products, conduct design verification & validation studies, review and approve protocols, studies, and perform general oversight responsibilities for the validation process, for both equipment and processes.

·       Conduct detailed root cause analysis and define corrective and preventive actions for NCR

·       Conduct Internal audits and Supplier audits against schedule

·       Develop Inspection plans for Incoming inspections, Inprocess and Final QA inspection for products manufactured

·       Detailed Review and approval of Risk Managements files

·       Review and Approval of Change Orders associated with components and manufacturing process,

·       Ensure that requirements laid down in the quality manual and standard operating procedures are adhered too, and provide advice and guidance to other departments on quality-related aspects.

·       Provide Operational QA Support for products and process.

·       Ensure correct and timely disposition of MRB material.

 

Qualifications /Experience required.

  • Degree in Quality, Engineering or a Science discipline.
  • 3-5 years' experience at quality engineering level within a regulated industry, preferably the Medical Device Industry
  • Previous Supervisory experience a distinct advantage
  • Demonstrable knowledge of FDA 21CFR820 and/or ISO 13485 regulations
  • Familiarity with the use of ISO 14971 is an advantage.
  • Ability to communicate effectively with management and peers, both orally and in reports
  • Good project planning and organizational abilities.
  • Strong interpersonal and communications skills, including oral and written reports.
  • Proactive with proven ability to work under own initiative, and strong team player.
  • Solid technical ability.
  • Willingness to travel to other Integra sites as part of duties.

Company offer's a competitive salary, good working environments with a growing well-established organization.

To apply contact mary.mullin@collinsmcnichoals or call 09064 78104