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PDS Tech Inc Quality Specialist in Fremont, California

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

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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