Title

Quality Assurance Specialist

Shift

M-F, 8:30 AM – 5:00 PM (flex hours available)

Location:

480 S. Democrat Road, Gibbstown, NJ 08027

Position Overview

Coordinate and/or assist with the day-to-day activities related to Keystone’s Quality Management System as identified below.

Essential Job Functions
  • Define/clarify cGMP and ISO standard requirements and help coordinate Keystone’s efforts for meeting them. Coordinate/revise/assist with the GMP/GDP training program and ISO Awareness program as needed
  • Oversee and coordinate quality system elements as assigned, including but not limited to the Internal Audit system, Customer Complaint Handling, Deviations, Non-Conformances and CAPA systems
  • Perform batch record reviews. Ensure proper follow-up and closeout of any issues and that appropriate documentation is completed and maintained
  • Assist with quality system documentation including but not limited to writing, revising and proof-reading Quality System Procedures, Keystone’s Quality Manual, department or task instructions, S.O.P.’s, checklists, forms, etc
  • Prepare and maintain product technical documents and Device Master Records, validation documents, change managements and other technical and quality system documents and records as necessary. Provide guidance to other personnel to ensure record requirements for project planning, design control, purchasing activities, customer complaints and other feedback, etc. are met
  • Assist with Management Reviews of the Quality System. Review and summarize trend analysis data as requested such as customer complaints, product and system non-conformances, returns and credit data, CAR/PARs, etc. Help prepare Management Review Reports, assist with data presentation and ensure appropriate meeting minutes are recorded and follow-up activities are performed and documented
  • Help ensure Executive Management’s company goals/objectives and plans for meeting them meet standard requirements, are documented, efforts measured, and results reported
  • Assist with project planning, design control and risk assessment responsibilities as necessary. Perform risk analysis and product Post Market Surveillance activities as required
  • Inform the V.P. of QA/Regulatory Affairs and Executive Management of problems found within the quality system and updates on improvements or necessary corrective actions
  • Assist with external regulatory, customer and ISO Notified Body audits. Help coordinate/document resulting corrective action closeout activities
  • Handle customer communication as necessary
  • Assist with other Quality Assurance and regulatory affairs activities as needed, including but not limited to product recalls/customer notifications, UDI and DSCSA activities, product and establishment registration requirements, etc
Qualifications
  • Minimum 3 years’ of Quality Assurance/ISO Quality System experience
  • Demonstrated FDA cGMP knowledge for medical devices. Pharmaceutical knowledge a plus
  • Understanding of current ISO 13485 and supporting ISO standard requirements
  • Demonstrated knowledge of system auditing techniques and requirements
  • Demonstrated knowledge of FDA’s complaint handling requirements
  • Proficiency in Microsoft Office applications (Outlook, Excel, Word, Powerpoint)
  • Exceptional interpersonal skills-ability to interface and communicate/collaborate at all levels internally and externally
  • Excellent writing skills
  • Ability to successfully work on multiple job tasks/projects simultaneously
  • Exceptional project management and organizational skills
  • Excellent time-management skills and deadline driven
  • High attention to detail
Education/Certifications
  • Bachelor’s Degree highly desirable but not mandatory
  • ISO Quality System Training
  • Internal Auditor Training
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