Job Listing Description

Quality Specialist

Description:
PDS Tech is seeking candidates for a Quality Specialist position in Fremont, CA

Major Responsibilities: 



  • Responsible for maintaining and updating Quality Systems (includes internal audits, customer complaints, corrective actions, non-conformances, product and process improvements) and Document Control (including, but not limited to standard operating procedures, specifications, quality manual, certificates, calibration reports, document change orders, product insert sheets)
  • Participate in internal audit activities
  • Provide Quality support for new products
  • Check and verify that change orders are accurate, properly cross reference all affected documents, and meets requirements for compliance with external customers, internal documentation and cGMP documentation practices
  • Processes complaints and non-conformances and monitors for trends
  • Verify that corrective actions are on schedule and support completion,
  • initiate and implement process improvements for the documentation system,
  • Assist in preparation for Quality Management System reviews
  • Manages periodic review processes and supports the generation of monthly document control metrics,
  • Provides additional support and assistance on tasks and projects with minimal direction from management,

Requirements:



  • BS Degree and/or minimum 2+ years' experience in biotechnology, medical devices, or pharma
  • Thorough knowledge of 21CFR820 and ISO 13485
  • Proficient in Microsoft Word and Excel; familiarity with Access, PowerPoint, and SmartSheets is a plus.
  • Ability to maintain confidential information, to meet deadlines, manage priorities, accuracy and attention to detail are critical.
  • Ability to transfer subject matter expertise and understanding to other employees and/or internal customers is required regarding why work is performed the way it is and how it impacts the broader organization.
  • Demonstrates strong understanding of Quality Systems fundamentals, Electronic Document Management Systems (EDMS) , knowledge of the process, effects, and the relationship between the document change process and products, and understanding of current Medical Device industry and applicable regulations including 21 CFR, ISO, GxP
  • Strong organizational skill to handle multiple projects
  • Strong written and verbal communication skills and ability to work with a wide range of personnel with varying technical skills and Quality understanding
  • Must exhibit professionalism, be an advocate for quality and self-motivated

 
Job Number: 2110124843
Job Location: Fremont, CA
Duration: 6 months
Input Date: 07/16/2021
Firm Name: PDS TECHNICAL SERVICES
Attention: Clyde Callwood
Address: 3922 COCONUT PALM DR STE 100
City, State: TAMPA, FL 33601
800 Phone: 866/224-2745
Email: southeastjobs@pdstech.com
Website: https://pdsjobs.force.com/candidates/job_detail?id=a1i1T000003PTITQA4&URLSource=cjhunter

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