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July 19 2018

    Job details


Job description:

   » Job ID.:15367759
   » Employer ID.:RI/AM16420
   » Published:12-JUL-2018
   » income:NEGOTIABLE
   » Job location:CLARE
   » Employment Type:PERMANENT


Senior Quality Engineer - County Clare.

In this function you will be required to manage process audits, and the development of Quality Management systems and connected documentation in the design and manufacture of medical device and connected products for global markets.
The prosperous candidate will be practiced in developing CAPA and NCMR systems and control plans ensuring that performance and product quality conforms to company SOP's, customer and regulatory guidelines.

Job Summary
• As a lead function, people management is an essential part of the function
• Manage key elements of the Quality System to ensure compliance to significant standards for the business including ISO 13485, FDA QSR.
• Provide quality input and support to the manufacturing, engineering, prototype and commercial functions.
• Strategically lead new product introduction and contract reviews from a QA perspective.
• Preparing and updating Operations procedures and connected documentation.
• Overall responsibility for functional area GMP standards and compliance including the promotion of Quality consciousness.
• Establishing inspection standards, plans, frequencies and test methods.
• Lead preparation and co-ordination activities for external audits and contact as required with SME's to ensure audits are conducted in an efficient manner.
• Responsible for generating Quality Performance data with the goal of identifying opportunities for improvements (CAPA).
• Develop strong links with customer organisations and other project stakeholders.
• Co-ordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
• Leading and managing investigations providing a formal structured approach to identify root causes, establish corrective actions and execute avoidance plans in products and/or processes.
• Use expertise of statistics to assist with process improvements, validation developments and process/product investigations.
• Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
• Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.
• Support the implementation of company policies and GMP
• Lead and co-ordinate preparation & on-going maintenance of FMEA's and Control Plans.
• Quality review of functional area validation documentation.
• Performing an active function in further development and continuous improvement of the quality management system.
• Supervision and direction of Quality personnel.

Interested candidates should bepracticed in developing Operations QA, CAPA, NCE systems and control plans ensuring that performance and product quality conforms to company SOP's, customer and regulatory guidelines. This is a lead function and will require the candidate to have people management practice.
Education & practice Required:
• Degree in Science or Engineering or similar technical discipline.
At least 7 years' practice in a Quality function, of which at least 3 years' practice in a Quality Engineering function with medical devices in FDA regulated environment.
• Strong working expertise of Quality Management Standard.
• Proven practice of Lean manufacturing / six sigma is highly desirable.
• Clean room / controlled environment practice desirable.
• Lead Auditor certification desirable.
This job originally appeared on


Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Clare
Company Type Employer
Post Date: 07/12/2018 / Viewed 12 times
Contact Information
Company: ICDS Recruitment

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