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Quality Specialist, Post Market

Company: Planet Pharma
Location: South San Francisco
Posted on: June 6, 2021

Job Description:

Overall Responsibilities:

The Quality Specialist, Post Market is responsible for providing subject matter expertise in Post Market quality assurance activities, including complaint handling and associated CAPA, audits, and training.

Top 3 Daily Responsibilities:

Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint. Perform and/or coordinate complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports. Evaluate all information to ensure appropriate analysis and investigation. 

Support other QMS areas as needed, including but not limited to: internal and external audit support; training development and management; CAPA investigations, corrective actions and effectiveness checks.

Support continuous improvement of quality system processes and procedures including developing and maintaining Standard Operating Procedures (SOPs).

Skill/Experience/Education

Mandatory

  • BA/BS degree in a technical field or equivalent practical experience.
  • At least 3 years of relevant work experience in the FDA QSR/ISO 13485 medical device industry.
  • Excellent communication skills and attention to detail.
  • Execute QMS activities with defined scope and complexity, and require minimal guidance from higher level team members.

Desired

  • Experience in project management, training, and working collaboratively with cross-functional teams.

Keywords: Planet Pharma, South San Francisco , Quality Specialist, Post Market, Other , South San Francisco, California

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