Quality Engineering Team Lead

• Develop validation plans for manufacturing processes; following company procedures
• Develop testing protocols to meet relevant regulations
• Review laboratory results prior to release of product
• Audit quality testing plans of suppliers to meet regulations
• In the event of a product complaint, conduct the appropriate investigating and testing
• Work with Marketing/Sales to develop appropriate response to customer complaints
• In the event of a product recall, work with the VP of Regulatory to develop a corrective action plan
Detailed Knowledge and Skills Required
• Lean manufacturing skills ( brown belt or black belt in 6 Sigma desired)
• Process validation
• Understands statistics to develop and drive sampling plans –
• Development of testing protocols to release product
• Good communication skills ( English a must)
• Team player mindset
• Ability and willingness to defend Quality position ( especially with regard to release of product for sale)
• Good leadership skills of both people and cross organizational processes in an effective and cooperative manner
Experience:
• At least 8 years of experience out of which 3 years working with an clinical Health Care company in a quality position in manufacturing/operation
• Working in a company with products across the spectrum of instruments, software and consumables
• Work with third party manufacturers to implement appropriate testing to ensure quality of products
• Former experience in people or process management
Education:
• BA in engineering related field