| Date Posted: | 14/Apr/15 | | Requisition: | 2060741 | | Job Title: | QA Operation Manager | | Description: | As a Quality Operation Manager for one of our two QA Operations teams with QA Ops you will take on a variety responsibilities. QA Operations is responsible for handling operational quality tasks with regards to equipment, production and product release of in vitro diagnostic medical devices (IVDs) in accordance to the IVD Directive, ISO9001, ISO13485 and FDA 21CRR Part 820.
The tasks in the teams include handling of deviations, NCRs, CAPAs, verification / validation efforts, Quality control, Product review and release, Quality reporting, etc. The manager should assure a responsive organizational quality culture and customer feedback focused team responsive to customer needs, regulatory compliance and business operation needs. | | Qualifications: | Education:
• Bachelors or master degree required in Engineering or Scientific discipline
Experience:
• Minimum 5-10 years working in QA from a FDA regulated industry, i.e. a pharmaceutical or medical device company
• Supervisory experience (i.e. managing direct reports), including hiring, training, coaching and performance management activities
• Strong knowledge of quality systems, including but not limited to ISO, GxP, FDA | | Company: | Dako | | Business: | Global Infrastructure | | Job Category: | Quality/Regulatory | | Job Sub-Category: | Quality/Regulatory Mgmt | | Region: | Europe | | Country or Area: | Denmark | | State/Province: | Capital Region of Denmark | | Town/City: | Glostrup | | Shift: | Day Job | | Job Type: | Experienced | | Schedule: | Full-time | | Travel Required: | Occasional | Duration
(Temp Positions Only): | Not applicable |
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