Mikroscan is looking for innovative people who want to help us improve the way pathology is practiced. We are a leading digital pathology company committed to providing technology-enabled products and services that increase a pathologist’s reach, remove barriers to workload efficiency, and enable new discoveries.
We are currently looking for a Quality Systems Specialist to join our growing quality systems team.
Summary
Responsible for the development, maintenance, and enforcement of document control and archival systems for Good Manufacturing Practices (GMP) records. The quality systems specialist ensures consistent quality of production, validates products and processes, provides documentation.
Duties and Responsibilities
- Accomplish quality assurance objectives by enforcing policies and procedures and conducting verification activities on incoming parts to finished goods
- Ensure DHR documentation is complete and accurate
- Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; assisting in audits; determining system improvements, and implementing change
- Develop quality assurance plans by monitoring procedures, corrective actions, and verification procedures
- Maintain the CAPA process and seek opportunities for continuous improvement
- Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification, and writing and updating quality assurance reports and procedures
- Maintain and improve product quality by assisting in product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs as well as manufacturing and training methods
- Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends including failed products, processes, corrective and preventive actions, and re-validations
Skills and Qualifications
- Prior experience and training in quality management systems, auditing, and manufacturing of regulated (medical) products is preferred
- Experience with process improvement, information analysis, and strategic planning
- Strong written and verbal communication skills
- Strong attention to detail
- BS-level degree in a related scientific or technical field
Other Duties
- Perform other duties, responsibilities, and activities as assigned
Benefits
- Employee health/dental/vision premiums paid in full
- 2 weeks paid time off
Job Type
Full-time
