Leinco Technologies, Inc. is looking for a Quality Assurance Associate who will maintain, implement, communicate, and develop our Quality System and Policy to ensure compliance with ISO9001:2015. Applicant must be familiar with Federal regulations (FDA & USDA), good manufacturing practices (GMP), and good laboratory practices (GLP). Ensure our Quality System and Policy is properly understood, carried out, evaluated, and if necessary, modified. Promote quality and performance improvement throughout the company and persuade reluctant staff to change their way of working to incorporate our Quality System and Policy. Define and write quality procedures in conjunction with operating staff. Perform “spot audits” to ensure operating staff are in compliance with our Quality System and Policy.
This position is different from standard laboratory work although lab interaction is critical. You work behind the scenes, making sure the essentials of our quality system are being followed. You have the opportunity for some laboratory work.
- Manage and maintain our quality inspection and release program for incoming and in-process materials and components.
- Manage manufacturing and quality control documentation for all manufactured materials. Including, establishing and assess product specifications for compatibility with customer requirements.
- Communicate with customers’ auditors to ensure compliance with customer.
- Manage and maintain calibration logs to ensure all required equipment is in compliance.
- Identify relevant quality related training needs and deliver needed training.
- Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to QA/QC.
- Monitor performance by gathering relevant data and providing statistical reports to the company’s management team.
Experience and Education:
- B.S or B.A. in an applied science or engineering field.
- Ideally 2 years experience in Quality Assurance including experience in quality management systems and quality system audits.