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Post Market Surveillance Specialist – Technical Writer

Santa Clara, CA
Amick Brown is seeking an experienced Regulatory Post Market Surveillance Specialist – Technical Writer for our direct client.
 
Location: Santa Clara, CA     
Duration: 6 Months

Reports to: Sr Manager, Failure Analysis Engineering

Job Description
  • Provides feedback to customers via Failure Analysis Letters.
  • Feedback includes a summary of failure analysis results, Instruction For Use (IFU) reminders, and recommendations for customer consideration.
  • ailure analysis letters can be written for all Intuitive products and platforms including the daVinci robotic assisted surgery system and Ion robotic assisted bronchoscopy system
Roles and Responsibilities
  • Creation and distribution of failure analysis letters based on completed failure analysis results
  • Managing failure analysis letters and backlog using software systems such as SAP and Trackwise
  • Work with translation vendors, as required, for letters outside of US
  • Provide clarification on failure analysis letter content when requested
  • Escalate feedback, comments, or concerns from customers or distributors based on failure analysis letters provided to end user
  • Escalate complaints to the Post Market Investigation (PMI) group as required
  • Interface with Failure Analysis, Customer Service, engineering, RMA, and clinical teams to gather information required for failure analysis letter content
  • Maintain library of similar responses in reference to failure modes, root cause, IFU reminders, and recommendations
  • Participate in process improvement activities to continuously improve process effectiveness
  • Execute on projects as required
  • Perform other duties as directed
Required Skills 
  • Education – English, journalism, or a communications undergraduate degree. Preferred Undergraduate degree in engineering, life science, or equivalent.
  • Experience – Experience with technical writing for a technical product and/or company. Preferred experience within the medical device field, with experience or exposure in the following areas:
    • Experience collaborating with engineering, scientists, and other specialists
    • General technical and or clinical medical device knowledge
    • Knowledge and understanding with Medical Device Complaint files and quality record documentation
  • Demonstrate strong written and verbal communication skills
  • Strong computer skills (SAP, Excel, Word, PowerPoint, database)
  • Efficient independent worker with ability to focus
  • Attention to detail
  • Demonstrate cross functional communication skills in email and in person
  • Excellent organizational and analytical skills
  • Ability to handle and manage workload independently
  • Prioritize numerous activities in a rapid paced environment
  • Contribute to team oriented tasks
  • Strong analytical skills
  • Strong interpersonal and decision making skills.
Competency / Training: 
  • Having the ability to devote time and energy to the vital activities that will make a significant impact or difference
  • General understanding of technical writing and ability to simplify complex topics.
  • General understanding of quality records requirements and how they apply to complaint files.
  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.

Regular full-time employees are eligible for the following Amick Brown provided benefits: 
  • Health
  • Vision
  • Dental
  • 401k with company match
  • Paid time off
  • Sick Leave
  • Short-Term Disability
  • Life Insurance
  • Wellness & Discount Programs

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