Jobot Kansas City, MO
- Expired: over a month ago. Applications are no longer accepted.
This Jobot Job is hosted by: Emma Goulden
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Salary: $100,000 - $120,000 per year
A bit about us:
We specialize in the development, manufacture and marketing of diagnostic test kits and equipment.
The quality and efficacy of our products is essential to ensure clinicians and patients are provided with a reliable, safe and robust method of diagnosis. It’s essential that we are always cognizant that a patient may receive a life changing diagnosis from one of our products.
Our company is made up of a wide range of people from different backgrounds and experience. Our goal is to have a friendly, inclusive and fun place to work which also supports the needs of our business.
Why join us?
- Medical, dental, vision coverage
- 401(k) with match
- Generous PTO and holidays
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
- The QA Manager has four reports, in Quality Assurance Specialist roles, engaged in quality system administration for the maintenance of FDA GMP and ISO quality system requirements.
- Excellent motivation and ability to remain on task without continuous or close management supervision.
- Excellent manager level leadership skills in role and ability to constructively resolve issues and apply continuous improvements.
- Excellent organizational and senior management level meeting skills for business operations management team activities and presentations.
- Ability to professionally represent the organization during site audits by the FDA, ISO and other international regulatory groups during sites audits.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- College degree in a scientific area related to Biology, Chemistry, Bio-Technology, Medical Technology, Regulatory Systems, or similar. Masters or PhD preferred.
- The position requires a minimum of 10 years of direct QA-RA related manager experience in a medical device, pharmaceutical, or veterinary medical environment with GMP, ISO, CE medical device related product production and support.
- The position requires demonstrated knowledge of quality systems, regulatory compliance programs and regulations.
- The position requires experience with management oversight of core program elements, including Complaint Handling, nonconformances, CAPA, Change Control, Label Control, Design Control, Validations, QC, Purchasing, Receiving Inspection, Calibration, Registrations and Document Control.
- Experience in technical writing and authoring policies, procedures, work instructions and customer support documents.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
AddressKansas City, MO
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