EKF DIAGNOSTICS Salary
AVON HOUSE 19 STANWELL ROAD PENARTH CF64 2EZ
TIN: 04260136
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Earnings on positions in EKF DIAGNOSTICS
EKF DIAGNOSTICS is looking for employees for positions:
quality assurance manager
Working hours
- full-time | Permanent
Requirements
- BA/BS degree in a science related field
- 5-10 years of experience in medical device or in-vitro diagnostic industry
- experience managing ISO 13485 Quality Management System
- excellent verbal and written communication skills, strong interpersonal skills, and superior organizational skills
- working experience with Lean and Six Sigma methodologies is a plus
- certified Quality Engineer or Certified Quality Audit is a plus
Responsibility
- directly manages site QA Team
- ensure that quality system requirements are effectively established and maintained in accordance with ISO 13485 and other regulatory requirements
- writes and updates standard operating procedures
- establish and maintain product assurance standards, procedures, and controls
- work directly with Human Resources to ensure local training programs are implemented which meet the Quality System requirements
- monitors the complaint handling process
- function as the direct link between Global QA and the regional site to ensure local strategies are developed and aligned in to support the global strategy
- manages the supplier program to include the selection, evaluation, re-evaluation and approval of suppliers