Careers < Quality Engineer

Description

Sequel is re-engineering life's essential products - starting with your tampon. Founded by two Stanford engineers and athletes, Sequel relies on fluid mechanics to finally give women the leak-free menstrual experience they need to perform at their best in the boardroom, the stadium, and beyond.

We believe that women are never truly prepared for their most critical moments when their products are not up to the standards that they should be. For modern active women who are breaking barriers and shattering glass ceilings today, the current selection of women’s health products are leaky tampons or bulky liners and do not measure up to their standards.

We are looking for a Quality Engineer that has experience with building medical devices and regulatory requirements.

The ideal candidate has experience working in a highly regulated environment, such as medical devices, aerospace, etc. An individual who would excel in this role would be a self-starter who thrives in a fast-paced, high-growth, results-oriented environment.

The primary responsibility of our Quality Engineer will be to identify areas for the 21 CFR 820, 21 CFR 801.430, 21 CFR 807.87, ISO 1345, ISO 10993-1 and -18 registration and maintenance for Sequel. This individual ensures the manufacturing and support activities of medical devices produced to meet the requirements of 21 CFR 820, 21 CFR 801.430, 21 CFR 807.87, ISO 1345, ISO 10993-1 and -18, and other applicable regulations and standards. This position supports both project management, process engineering, regulatory, and operations through all phases of our medical products’ lifecycle. In addition, they will be involved in the QMS Quality module and internal audit process.

The challenge and benefit of this role are that the responsibilities in this job are multifaceted and require a high degree of flexibility in the day-to-day activities.

Experience with a QMS is a definite plus but not required.

Key Responsibilities

  • Maintain Medical Device Quality System Knowledge for 21 CFR 820, 21 CFR 801.430, 21 CFR 807.87, ISO 1345, ISO 10993-1 and -18
  • Participate and assist in internal and external audits.
  • Regular, on-time attendance at work.
  • Strong organizational and time management skills.
  • Develop inspection methods to analyze product quality.
  • Improve product quality by making recommendations for change.
  • Work together with relevant teams and departments to implement and improve products.
  • Ensure products adhere to company and industry quality standards.
  • Brainstorm ideas to create solutions for identified problems.
  • Formulate a strategic plan to increase productivity in the business.
  • Document results and findings after inspections are carried out.
  • Implement a working system to ensure conformity and accuracy in the production process.

Qualifications

  • 1-3 years of engineering experience in the medical device industry preferred
  • College Degree in Engineering preferred or relevant work experience
  • Experience as Quality Coordinator/Technician/Inspector
  • Previous experience in quality tools, mistake proofing, and IQMS
  • Medical product knowledge
  • Collaborative individual

Please submit your application here.  Include a profile, availability, hourly rate and references.

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