Quality Assurance Specialist
Cygnus Technologies is seeking a Quality Assurance Specialist responsible for the implementation, maintenance, and continuous improvement of the Quality Management System including the review and approval of deviations, NCMRs, CAPAs, supplier management, change controls, and controlled documentation management, etc. Provides review and approval for products and new product development documentation. Tracks and reports on quality metrics. Ensures compliance with company policies and procedures and applicable domestic and international standards and regulations, including but not limited to ISO 9001:2015.
- Ensures compliance to ISO 9001:2015 to maintain certification
- Ownership for QMS system processes for nonconformance, deviation, complaint, CAPA, etc.
- Responsible for reviewing and approving Quality Events (e.g. deviations, NCRs, CAPAs, Change Control, and complaints) to ensure appropriate investigations are completed timely.
- Ensures Change Control of materials, equipment, processes, procedures include appropriate documentation
- Assists with document and record control functions as needed
- Provides oversight for training program and conduct quality related training
- Conducts quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
- Leads cross-functional teams in risk identification and mitigation activities.
- Reviews product documentation for disposition of finished goods.
- Compiles, maintains, and reports quality metrics to ensure visibility of QMS health, including creating trending graphs for weekly, monthly, and quarterly reports.
- Participates in the audit program, including conducting internal audits and hosting external quality audits, as needed (e.g. customers, ISO, etc.).
- Assures compliance with all in-house or external specifications to standards such as ISO or customer requirements. Works with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.
- Supports supplier quality by maintaining the approved supplier list, administering supplier surveys, quality agreements, approved supplier list, and performing critical supplier audits as needed.
- Leads Quality improvement projects.
- Identifies quality issues/ discrepancies and effectively resolve these within the organization.
- Performs other duties as assigned.
- Quality professional with a minimum of 3-5 years relevant experience in a life science industry.
- Requires knowledge of ISO 9001 standards (or ISO 13485)
- Strong and effective verbal and written communication skills.
- Strong interpersonal, teamwork and customer interfacing skills.
- Strong problem-solving skills and analytical skills applied to investigations.
- Self-motivated and able to organize and prioritize multiple tasks.
- Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
- Proficient in Microsoft Office
- Experience with NetSuite ERP and MasterControl is a plus
Cygnus Technologies offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.
Cygnus Technologies is an EEO Employer.
- Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).