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QUALITY ENGINEERING MANAGER
Company:CAREERWISE RECRUITMENT |
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Job Reference Number |
14571579 |
Client ID: |
RI/CW116322 |
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Posted On: |
Feb 21 2012 |
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Location: |
ATHLONE, WESTMEATH |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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Contact Tom Devaney on +353-91-758771 for more information
CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.
Position Summary
Responsible for ensuring that new products and changes to existing products follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to Quality and R&D engineers on design controls, risk management, verification and validation practices, and statistical methods.
THE ROLE:
*Oversee and manage Quality Assurance Engineers who provide quality support in design and development of medical device products.
*Manage department resource allocation across multiple product lines.
*Provide design control and design transfer guidance to manufacturing facilities.
*Author design control and risk management procedures.
*Provide training to R&D engineers on design control and risk management procedures, and statistical methods.
*Interact with FDA inspectors and auditing body agencies during audits.
*Drive change, demonstrate effective decision making, and provide direction for quality operations.
*Provide guidance and advancement opportunities for department employees.
REQUIREMENTS:
*BS or MS in an engineering or scientific discipline
*8 to 10 years experience in a quality engineering or management role
*Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
*Skilled in test methods and standards for the design, verification, and validation of medical device products.
*Experienced in product risk assessment to the requirements of ISO 14971.
*Skilled in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments.
*Good verbal (including presentation) and written communication skills.
*Effective coaching and mentoring skills.
*Familiar with reliability analysis and test methods.
*Manufacturing engineering or manufacturing quality engineering experience preferred.
*ASQ CQE or CRE certification.
*Spanish proficiency desirable.
