Overview
Sr Manufacturing Quality Engineer Jobs in Greenville, TX at Synapse-ITS
We are currently seeking a proactive, reliable, and experienced Quality System and Document Control Specialist with outstanding interpersonal and technical skills. Interested candidates should have GxP and/or Clinical Laboratory Improvement Amendments (CLIA) experience.
Employment Type:
Full time
Key Responsibilities:
· The Quality System and Document Control Specialist is responsible for coordinating and managing quality documentation within a controlled system
· They work with product development, marketing, operations, regulatory, quality, and science departments to ensure procedures are followed and records are maintained for the products and services provided.
· They ensure the Quality Management System (QMS) is properly maintained and compliant with regulations and customer requirements.
· Ensure and support compliance with the company’s Quality Manual, Quality Policy, and Quality Objectives
· Develop quality metrics and coordinate the data collection and analyses for Management Reviews
· Participates in internal and external Quality Audit processes with internal customers and third parties, including regulatory organizations
· Monitor and maintain periodic review of documentation
· Monitor and maintain the training program
· Document and evaluate changes through the internal change control process
· Coordinate with various departments to ensure effective and timely task completion
· Accepts and adapts to change as directed; understands change is a constant and necessary path for improvement and growth
· Other duties as needed.
Qualifications:
· Bachelor’s degree in quality assurance or science-related field.
· Minimum of 3 years in document control and/or quality system operations.
· Extensive QMS knowledge including ISO 9001.
· Experience participating in internal and external audits
· Experience with CAPA, complaints, risk management, and supplier management
· Strong management skills, including the ability to facilitate and organize
· Ability to effectively communicate with customers and regulatory agencies
· Ability to communicate effectively with subordinates and motivate personnel to achieve efficient workflows and methods
· Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines
· Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.
· Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.
· Strong advanced computer skills.
· Experience with eQMS (Qualio) is a plus.
Job Type: Full-time
Pay: $65,000.00 – $80,000.00 per year
Benefits:
401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Work Location: In person
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Title: Sr Manufacturing Quality Engineer
Company: Synapse-ITS
Location: Greenville, TX
