General Information:
Sartorius is looking for Quality Associate in Arvada CO
Reports to: Quality Manager
Position Summary:
- At the Arvada site, administer and oversee the requirements defined by the North America quality management system to ensure that products manufactured at the site consistently meet performance and quality specifications.
- Additionally ensure that all processes related to the distribution of products meet local and global policy requirements.
- Assist as needed to ensure that the North American quality management system is properly managed and maintained.
Essential Duties and Responsibilities:
- Ensure that the Arvada site complies with established quality requirements for ISO 9001 and GMP’s for the controlled distribution of products including medical devices
- Perform incoming inspection of all raw materials and components used for manufacturing
- Release finished products for distribution
- Perform any required CAPA or Deviation investigations
- Assist Process Engineer with the investigation of any customer, vendor, and internal quality issues or complaints
- Create, review and sign off any related documents or records
- Ensure applicable equipment used in manufacturing is properly calibrated, and preventive maintenance schedules and activities are maintained
- Perform quality check of all products received for distribution and required inspections of all returned products
- Ensure that returned products requiring complaint investigation are dispatched to the proper quality group
- Ensure that any quarantined products are controlled properly and cannot be used in manufacturing or placed into distribution
- Perform internal audits for compliance to the quality management system
- Assist site management team as needed to meet site quality goals and objectives
- Assist North American Corporate Quality with the collection of data for the management review
- Perform vendor quality system audits for North American vendors
- Perform site registration with FDA for importer distributor of medical devices
- Keep track of all data related to the handling or distribution of medical devices in North America
- Assist Corporate Quality in New York as needed regarding North American quality issues
- Assist in hosting third party audits in Arvada
Qualifications and Requirements:
- BS in any Quality/Engineering/Science discipline with 3-5 years’ experience, or AS in any Quality/Engineering/Science discipline with 5-7 years’ experience
- Knowledge of manufacturing and distribution
- Knowledge of ISO-9001, and current FDA Good Manufacturing Practices
- Understanding of quality systems methods
- Experience in internal auditing and vendor auditing
- Problem-solving and analytical skills
- Good verbal and written communication skills
- Ability to work independently and in a team environment
- Able to interact with all levels inside and outside the organization
- Some physical work required – must be able to lift 50-lbs
- Strong Microsoft Office skills
- Traveling is expected, ~15%
Additional Comments:
- All qualified applicants will receive consideration for employment without regard to race, creed, color, or national origin.
If you are interested in this opportunity, please apply online at http://www.sartorius.us/us/company/careers/vacancies/job/show/8349
