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June 20 2018

    Job details

Offer: SENIOR QUALITY ENGINEER:CareerWise Recruitment

Job description:


   » Job ID.:15358799
   » Employer ID.:RI/CW121357
   » Published:14-JUN-2018
   » income:NEGOTIABLE
   » Job location:CLARE, CLARE
   » Employment Type:PERMANENT

 

A Senior Quality Engineer is required by CareerWise Recruitment for our client who are located in Clare. The Senior Quality Engineer is required to manage; process audits, 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, NCMR systems and control plans ensuring that performance and product quality conforms to company SOP's, customer and regulatory guidelines. Reporting to Quality Manager and as a lead function, People Management is an essential part of the function. Contact Us by Tom Devaney for more information.

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 coordination 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 in identifying opportunities for improvements (CAPA).
* Develop strong links with customer organisations and other project stakeholders.
* Coordinate 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
* Provides additional support and assistance on tasks and projects as directed by management
* Lead and coordinate preparing & on-going maintenance of FMEAs 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.

Requirements:
* The candidate will be practiced 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.
* Level 8 Degree in Science or Engineering or similar technical discipline.
* 7 years' practice in Quality function, of which 3 years' practice in a Quality.
* As an Engineering function with medical devices in FDA regulated environment you will need: - 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.

CareerWise Recruitment accepts that you do not wish your CV to be mailed to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.

Please call Tom Devaney today For more information on 091-758771 or Email address: tdevaney@careerwise.ie

CareerWise Recruitment
In Search of Excellence
We provide recruitment services in the areas of Engineering, Supply Chain, Sciences, Information technology and Accounting & Finance.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin.
Supporting Business Demands & Growth since 1999
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: Clare
Company Type Employer
Post Date: 06/14/2018 / Viewed 13 times
Contact Information
Company: CareerWise Recruitment
Contact Email: tdevaney@careerwise.ie


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