We have Job Opportunity for QA Engineer at Eugene OR with direct client
Duration- 6+ months extendable
We are looking for ..
o Bachelor/Master degree with at least 5 years relevant experience in Quality Assurance
o Background in a Regulated Industry, Medical Devices, IVD or Pharma, is required
o Experience in setting up and maintaining compliant Quality Management Systems is required.
o Experience with manufacturing quality control is a strong preference.
o Practical knowledge of medical European and US standards and regulations is a strong preference
o Proven track record in integration of corporate quality systems is a plus.
o Experience with design controls in Software Development environment is a plus.
o Excellent verbal and written communication skills (English)
o Strong communication and influencing skills
We are looking for a quality professional to align quality practices of a smaller, recently acquired medical device business to the QA standards.
The challenge is to integrate a fast growing business in a corporate structure and improve quality practices, while minimizing disruption.
For this you will need in-depth knowledge of relevant Quality Assurance practices, in particular: design controls, design transfer and quality mgmt. processes.
You work closely with Product Development, Operations, Service, Supply Chain and Marketing & Sales.
You ensure compliance of the Quality Mgmt. System (QMS) with relevant standards and regulations.
• Support integration of a recently acquired medical device business in the organization.
• Execute Q-improvement and integration plans.
• Collaborate with other functions and departments on QA related aspects.
• Ensure released products are developed, manufactured, distributed and serviced at the right quality levels, in compliance with relevant regulations and Philips policies.
• Ensure Quality & Regulatory aspects are adequately covered in the selection, control and monitoring of suppliers.
• Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement. Drive compliance, effectiveness and efficiency of the QMS and operations.
• Collaborate with Business and Q&R Management to establish strategic plans and objectives
• Establish and track quality objectives
If you have the above qualification and interested to apply please reply with your updated resume, contact no. and expected pay rate and I will contact you to discuss further.