Information:

This job has been filled.

Job Vacancy Details

Quality Assurance Manager

Chem/ Pharm

West Midlands

Permanent

Updated September 17, 2008

Our Client is looking to recruit an Individual to lead Quality Assurance and Regulatory affair functions in accordance with their Quality system and Device Directives. Objectives include-
• Assure ISO compliance by developing procedures and auditing departments on a routine basis
• Conduct quarterly Management Review meetings to provide management with an assessment of the quality system and measures to drive improvement
• Assist Director of Quality in development of annual quality plan
• Responsible for Corrective and Preventive Action (CAPA) and Customer Complaint Handling programs
• Visit customers to resolve complaints
• Work with Director of Quality and Engineering to incorporate new or revised regulatory requirements
• Assure that Design Control Process is properly adhered to by assuring the design reviews are conducted and validations are performed
• Assure technical files are completed and in compliance with ISO requirements
• Work with Field Engineering and Product Engineering to drive product quality improvements in an expeditious manner
• Work with suppliers to assure compliance to specifications
• Work with suppliers on design/ process improvements and corrective actions noted from field issues
• Develop internal audit program and assure audits are conducted in a timely manner
• Manage calibration program to assure both facility and field engineering equipment is properly maintained
• Indoctrinate new employees into the Company and educate them on the quality systems and practices in the organization and the Quality core value.
• Conduct team training, as needed, to reinforce existing quality system policies and inform as to new or revised policies.

Who we're looking for
Extensive Quality Engineering experience to include medical device experience.
Key Qualifications:
BS degree in Electrical or Mechanical Engineering.
Ability to build strong relationships and demonstrated ability to influence and drive change and policy implementation within a business.
Experience in tracking and driving improvement in quality metrics through process or design changes.
Production QA (design) hands-on experience.
Supplier QA engineering hands-on experience, including audits.
Design control hands-on experience.
Knowledge of ISO9000, health and safety standards and HTM2030 preferred, ISO 9000 quality system implementation a plus.
Detail orientation and bias for action, along with self-starter working style.

About our client
Our Client is a Market Leader in the Healthcare Industry

What's on offer
An excellent salary and package is available

Michael Page Contact
For further info, apply or phone on +44 (0)121 230 9380. Job Ref: 12972244
Your application will be sent to Martin Crowley.