| Location: |
Minneapolis, MN |
| Territory
Covered: |
Home Office Based (MN) |
| Specialty: |
| Clinical Research- Medical Device/Oncology |
|
| Description: |
• Responsible for the execution of the Quality System Management Review process to determine the effectiveness of the site quality system
• Manage the company’s complaint program including analysis of complaint trends and determination of corrective actions (CAPA)
• Responsible for the development, maintenance and implementation of the CAPA, and Audit Processes.
• Liaise with Manufacturing and R&D to ensure the company maintains quality compliance
• Manage surveillance on new product and product revisions including defect investigation/response
• Ensure all activities of the Quality Control department is executed in a timely manner
• Develop and implement Quality and compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance
• Establish, maintain and improve reports of quality data such as customer satisfaction, business level quality, and functional area quality indicators to assist in continuous improvement
|
| Job
Requirements: |
• Bachelors degree in Life Sciences or a related field (Engineering degree highly preferred)
• Minimum of 3 years experience in Quality Assurance for a medical device company
• Must have complaint management experience and strong CAPA expertise
• Excellent problem solving and communication skills
• Must be able to function effectively in a culturally diverse team environment
• Must be detailed oriented |
| Compensation: |
Compensation package includes competitive salary commensurate with experience. |
| Benefits: |
Medical and Dental |
| Travel
Requirements: |
0-10% |
|
|
