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January 20 2018

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Job Opportunity: QUALITY ENGINEER- MEDICAL:ICDS Recruitment

Job description:


   » Job ID.:15312249
   » Employer ID.:RI/RS 16213
   » Published:12-JAN-2018
   » income:NEGOTIABLE
   » Job location:OFFALY
   » Employment Type:PERMANENT

 

Quality Engineer- Co. Offaly

Responsibilities
Your k ey function is to proactively support quality engineering activities with regards to the Quality Management System specifically Supplier Management and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations. This is an essential function in the overall strategy for improved assurance of continuity and improvement of the established QMS, delivered product quality and to support growth of the Company.

ESSENTIAL tasks AND RESPONSIBILITIES
   » Maintain oversight of current suppliers and assess potential new suppliers and service providers for technical, quality, and quality system capabilities.
   » Implement continuous and innovative improvements with demonstrated and measurable results – e.g. Dock to Stock Program, Cost of Poor Quality
   » Drive the supplier audit program through managing and conducting supplier audits per schedule. Ensure proper root cause is determined and implemented by the supplier when there is a finding.
   » Evaluate nonconforming supplied material and prepared Supplier Correction Action Requests (SCAR) to effective resolution of root cause problems contributing to unsatisfactory supplier quality performance.
   » Ensure supplier files are compliant with regulations and internal procedures.
   » Partner with Site purchasing & integrate Division Supplier Quality team to leverage cross site competencies and drive improvements.
   » contact with Operations, Supply Chain Management, Warehouse, Engineering and PD to ensure uninterrupted supply of materials.
   » Support NPIs by providing guidance on compliant adherence to company requirements as defined in material specifications, CTQ's, process control plans, quality agreements and other defined requirements.
   » 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.
QUALIFICATIONS/practice
   » Degree in Quality, Engineering or a Science discipline.
   » 3-5 years' practice at quality engineering level within a regulated industry, preferably the Medical Device Industry
   » Demonstrable expertise of FDA 21CFR820 and/or ISO 13485 regulations
   » Audit practice in conduction supplier and or internal audits
   » Certified Lead auditor qualification for 13485 is an advantage.
   » expertise in statistical methods
   » Familiarity with use of ISO 14971:2007 an advantage.
   » capability to communicate effectively with management and fellow peers, both orally and in reports
PERSONAL COMPETENCIES
   » Good project planning and organizational abilities.
   » Strong interpersonal and communications expertise, including oral and written reports.
   » Pro-active with proven capability to work under own initiative, and strong team player.
   » Solid technical capability.
   » availability to travel as part of tasks.

This job originally appeared on RecruitIreland.com

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Offaly
Company Type Employer
Post Date: 01/12/2018 / Viewed 13 times
Contact Information
Company: ICDS Recruitment


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