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Sr IQC Inspector

Visby Medical

Visby Medical

San Jose, CA, USA
Posted on Thursday, September 14, 2023

About Visby

Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.

ABOUT THE JOB

The Sr. INC Inspector will support the release of material to the Production Line and finished product. The position interacts with all levels of employees and management. The nature of these interactions includes answering release criteria questions, problem-solving and quality and compliance issues. This position requires independent thinking, interpersonal and communication skills. The problems are usually quality or compliance related in nature.

HOW YOU’LL MAKE AN IMPACT

  • Support testing and inspection of incoming materials and final product, collect data, process material, and provide feedback to engineering as required.
  • Document Inspection results.
  • Analyze data and clearly articulate your findings verbally and in writing to Engineers and Quality.
  • Perform first article inspections as needed.
  • Assist in creating material flow / Work Instruction (WI), Batch Record / Traveler in accordance to GMP / QMS where applicable.
  • Escalate inspection issue(s) to Quality / Engineering / Production / Material Control clearly and effectively in a timely matter.
  • Follow established quality policies and adhere to operating procedures / guidelines.
  • Other duties as assigned.

ON YOUR FIRST DAY WE’D LIKE YOU TO HAVE

  • 5+ years in a medical device production environment (FDA regulated Medical Device industry is a plus).
  • Good knowledge of Manufacturing (injection molding a plus) with a Quality mindset.
  • Good organizational skills.
  • High School level equivalency (English reading / writing proficiency).
  • Must be able to read, interpret, and apply GD&T Principles
  • Strong computer skills with a good knowledge of Microsoft Word, Excel and Adobe.
  • Must have experience using hand measurement tools such as calipers and drop gauges.
  • Experience with basic metrology tools such as MicroVu and/or Keyence with a quality mind set and attention to detail.
  • Able to follow written / verbal instructions with minimal supervision.
  • Perform repetitive tasks with consistency and accuracy.

UNIQUE ASPECTS OF THIS JOB

  • Travel: No travel
  • Schedule: Standard M – F, with flexible start/stop time.
  • Physical aspects: Comfortable performing repetitive tasks and/or motions. Must be able to lift a minimum of 10 lbs.

SALARY RANGE:

  • $28/hr - $36/hr (Minimum to maximum salary range for candidates based in San Jose, CA)
  • Compensation for the role is based on geographical location.
  • Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.

More about our benefits

Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also offer a 401k match, flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.

Additional information

We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.

Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.