Pay Range:

Position Summary:  

Engages in planned and systematic activities to provide confidence that requirements for quality and quality improvement are being met. The Quality Assurance Specialist recommends revisions to, or creation of, new protocols, policies, procedures and/or systems as a result of analysis. Understands concepts of ISO 13485 and FDA Quality System Requirements. 

Key Responsibilities:  

• Document Control activities using an electronic database 
• Conduct internal audits on a periodic basis according to an established scheduled plan 
• Prepare written audit reports and all activities and report findings. 
• Prepare quality records and for regulatory inspections.  
• Assist with batch record review and release of approved materials or place material on hold. 
• Review and/or write nonconformances and CAPAs.  Prepare and host Materials Review Board and CAPA Review Board meetings.  
• Assist with maintaining and monitoring Quality Assurance specific quality indicators. 
• Help prepare data for Management Review 
• Write validation plans and reports 
• Execute validations 
• Write, review and/or revise QA SOPs 
• Other quality related duties as required by QA management 

QUALIFICATIONS 

Education and Experience: 

• Strongly Preferred a B.S. or B.A degree in a related science, engineering, or a related field. 
• At least 3 years of experience in a QA function for the Sr. Quality Assurance Specialist role. 
• Certifications such as ASQ CQE, CQA, or Lead Auditor certifications are preferred. 

Knowledge, Skills, and Abilities: 

• Demonstrated experience with Document Control processes, experience with an Electronic Database a plus 
• Demonstrated an understanding of QA regulations and best practices 
• Excellent verbal and written communication skills, strong interpersonal skills, and a demonstrated ability to manage multiple activities while maintaining a high level of organization. 
• Working experience as a lead auditor.   
• Ability to lead nonconforming material investigations, write reports, and determine material dispositions in a timely manner while maintaining compliance. 
• Proficiency in CAPA processes and requirements within each phase. 
• Strong understanding of IVD product risk management requirements under ISO 14971.   
• Ability to write validation protocols and reports. 
• Basic understanding of statistical techniques and sample size rationale. 
• Capable of evaluating technical and scientific data and reports to determine their validity.  
• Proficiency with Microsoft Office Suite, ability to utilize Excel for data analysis and production of charts and tables. Production of reports in Word, PowerPoint, etc 

Working Conditions: 

• Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment. 
• Standard schedule hours with occasional variation depending on production needs. 
• Onsite work required during standard business hours.  

Physical Requirements: 

• Ability to lift and handle materials weighing 5–50 lbs. 
• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods. 
• Manual dexterity required for laboratory equipment and fine measurement techniques. 
• Ability to work at a computer for extended periods.