QA Specialist (1-year Contract)

Posted 5 Hours Ago
Be an Early Applicant
Seoul, KOR
In-Office
Entry level
Healthtech
The Role
Support post-market surveillance and QMS activities including complaint handling, adverse event and UDI reporting, document control, regulatory communications, QMS improvements, cross-functional QA projects, and general QA administrative tasks.
Summary Generated by Built In
Work Flexibility: Hybrid

Key areas of responsibility

  •    Support post-market surveillance (PMS) activities, including complaint handling, product field actions, adverse event reporting, UDI reporting, and other activities in accordance with applicable local regulatory requirements.
  •    Support Quality Management System (QMS) activities to ensure compliance with internal procedures and applicable regulatory requirements.
  •    Support the maintenance and control of QMS documentation, including procedures, work instructions, forms, and quality records.
  •    Support communications and document preparation for regulatory authorities and Notified Bodies, as applicable.
  •    Assist with QMS improvement initiatives and process updates under the guidance of the QA team.
  •    Assist with cross-functional QA projects and support QMS-related systems and documentation.
  •    Perform other QA administrative and operational tasks as assigned.

Education / work experience

  • BS in a science, engineering, business or related discipline.
  • 0+ years experience in manufacturing environment or equivalent.

Knowledge / competencies

  • Good command of written and spoken English.
  • Strong documentation skills with attention to detail.
  • Basic understanding of Quality Management System (QMS) and applicable regulatory requirements.
  • Proficiency in Microsoft Office applications (Excel, Word, and PowerPoint) and data management.
  • Strong communication and interpersonal skills with the ability to work effectively in a cross-functional environment.
  • Good organizational and problem-solving skills with the ability to manage multiple tasks.

Travel Percentage: None

Skills Required

  • BS in a science, engineering, business or related discipline
  • 0+ years experience in manufacturing environment or equivalent
  • Good command of written and spoken English
  • Strong documentation skills with attention to detail
  • Basic understanding of Quality Management System (QMS) and applicable regulatory requirements
  • Proficiency in Microsoft Office applications (Excel, Word, and PowerPoint) and data management
  • Strong communication and interpersonal skills with ability to work cross-functionally
  • Good organizational and problem-solving skills with ability to manage multiple tasks

Inari Medical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.

  • Fair & Transparent Compensation Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
  • Healthcare Strength Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
  • Leave & Time Off Breadth Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.

Inari Medical Insights

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The Company
HQ: Irvine, CA
956 Employees

What We Do

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

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