Quality Systems Specialist
About The Position
The Quality Systems Specialist supports the development, management, maintenance, control, and continual improvement of the Quality Management System (QMS), including related processes, procedures, work instructions, and records. The role has key responsibilities for the Nonconforming Product (NCP) process and the Inspection, Measuring, and Test (IMT) equipment process, and contributes to implementation and continued support of an electronic QMS (eQMS). The position supports quality planning, nonconforming product control and investigation, equipment calibration, corrective and preventive actions, complaint handling, internal and external audits, quality training, process control and improvement, and document and record control. It also monitors quality objectives and key performance indicators and assists with special projects. The role interfaces with all levels of the organization, including management and staff, as well as customers and suppliers; confidentiality is important.
Requirements
- A bachelor's degree in a Life Science or Engineering discipline and three years of quality-related experience in a manufacturing industry, or five years of direct Quality or Regulatory-related experience.
- Practical experience or training in quality planning, NCR systems, calibration programs, corrective/preventive action systems, quality auditing, root cause analysis, and problem solving is highly desirable.
- Good knowledge and skills using advanced personal computer productivity programs for word processing, spreadsheets, database manipulation, cloud-based software, and flow.
- Working knowledge of ISO 13485 quality systems and/or FDA 21 CFR 820 quality requirements.
- Ability to interface with all levels of the organization, management and staff, customers, and suppliers.
- Ability to handle confidential information.
Nice To Haves
- Experience implementing eQMS software or substantial experience using eQMS software is highly preferred.
- Practical experience or training in quality planning, NCR systems, calibration programs, corrective/preventive action systems, quality auditing, root cause analysis, and problem solving.
- Metrology knowledge covering equipment usage, data analysis, units and unit conversion, regulatory requirements, and industry best practices.
Responsibilities
- Write and execute quality plans and establish quality control points to monitor progress and achievement of those plans.
- Contribute to implementation and continued support of an eQMS, particularly for the NCP and IMT processes.
- Oversee identification, tracking, control, and quarantine of nonconforming product.
- Review nonconforming product to determine its source and root cause and help prevent recurrence.
- Conduct risk analyses to assess whether proposed product dispositions are appropriate and acceptable.
- Review and approve NCR dispositions and maintain related documentation and records.
- Oversee routine calibration activities for IMT equipment, perform in-house calibration, and facilitate out-of-house calibration.
- Investigate events involving equipment found out of calibration and maintain related documentation and records.
- Escalate issues arising from key responsibilities to the CAPA program.
- Assist the Quality Engineer with investigations, corrective or preventive actions, and effectiveness checks as needed.
- Assist with complaint reviews and actions arising from complaint outcomes, including communication to production and training activities.
- Conduct internal audits according to the audit schedule or as assigned; prepare checklists, conduct interviews, document findings, and follow up on audit nonconformities.
- Participate in external audits as assigned.
- Provide quality training throughout the company and model adherence to processes and procedures.
- Review manufacturing, QC, and other quality and operational processes to ensure they are adequately controlled.
- Establish quality control points throughout the facility and work with department supervisors to identify and implement improvements that reduce variation and improve quality.
- Support the document control team as assigned and maintain records according to established processes and procedures.
- Monitor implementation and progress of quality objectives and regularly track and update QMS effectiveness indicators.
- Assist with related special projects as required.
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What This Job Offers
Job Type
Full-time
