Quality Specialist II

Organization
Invivoscribe Technologies Inc.
Job Location
San Diego, CA 92121
Salary
Salary is commensurate with experience.
Benefits
  • Competitive salary that is commensurate with experience.
  • IVS provides health, dental, and vision coverage, Life/AD&D, short-term and long-term disability, paid vacation, sick time and holidays and a 401(k) retirement plan with generous employer match, among other benefits.
Job Description
  • Manages CAPA, NCMR, and Deviation systems.  Prepares CAPA, NCMR, and Deviation metrics for Management Review.

  • Assists in external and internal auditing of suppliers and IVS QMS.

  • Supports activities regarding supplier qualification and performance. Assists in review of supplier files for compliance to appropriate GMP standards.

  • Reviews and approves validation protocol and reports.

  • Performs some trainings for GMP, GDP, ISO 13485, etc.

  • Cooperates and respectfully communicates with external and internal customers.

  • Other duties, as assigned.

Requirements

Skills / Knowledge / Abilities

  • Meticulous and detailed oriented.

  • Ability to consistently meet critical deadlines.

  • Ability to follow Standardized Operating Procedures (SOPs), as well as written and verbal instructions.

  • Ability to work independently as well as in a team environment.

  • Excellent written and verbal communication skills with the ability to train employees.

  • Ability to manage multiple projects and changing priorities.

  • Demonstrated ability to learn and take on new challenges.

  • Education and Experience

  • Requires BA/BS degree.

  • 2+ years experience in medical device quality departments.

  • Experience in writing QMS documentation.

How to Apply

SPECIFY THE POSITION AND APPLY AS FOLLOWS:
- Submit your resume and cover letter to [email protected]
- Be sure to reference Job Code: JTQASII in the subject line of either your email or cover letter to be considered for this position.
- No phone calls or walk-ins inquiring about this position.

About Our Organization

Invivoscribe Technologies, Inc., is a privately-held corporation dedicated to improving the quality of healthcare worldwide by providing high quality, reliable, cutting-edge tools for molecular research, molecular diagnostics, and personalized molecular medicine.

Invivoscribe provides a comprehensive selection of PCR-based gene rearrangement, chromosome translocation, and gene mutation Research Use Only testing reagents and controls. We also provide CE-marked in vitro diagnostic products to customers outside North America, and our subsidiary. Customers include many of the world's leading pharmaceutical and biotechnology companies, medical centers, cancer research centers, reference laboratories and molecular testing centers.

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