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Quality System Lead

Science

Science

Quality Assurance
Alameda, CA, USA
Posted on Tuesday, May 16, 2023

Science is an early stage company developing technologies for a range of serious unmet medical needs. We are unafraid to take difficult technical risks, secure in the knowledge that with a clear understanding of what we are doing and with support from powerful modern tools, more progress is possible than might be immediately obvious. Regardless of role or team, the two most important factors we look for in a candidate are evidence of exceptional ability and the addition of positive energy to the group. As a small, very early stage team in a largely unstructured environment, the ability to independently orient yourself to the problems that need to be solved and then follow through is essential.

The Quality System Lead oversees the document control system and oversees completion of training, authors SOPs, and leads audits.

Roles and Responsibilities:

  • Implement a Quality Management System to FDA 21 CFR Part 11 for release and archival of documents whilst collaborating with Regulatory for appropriate signatories
  • Ensure training documentation of awareness and competence
  • Author SOPs for Quality Management to 21 CFR 820
  • Lead quality system audits of external suppliers and maintain an Approved Supplier Log with familiarity of ANSI/ASQ Z1.4 and Z1.9

Qualifications:

  • 10+ years working in medical devices to ISO 13485 or labs to ISO/IEC 10725 with increasing roles of responsibility
  • GMP and/or GLP
  • Bachelor’s degree
  • Openness and a growth mindset
  • Excellent communication and ability to work collaboratively as a team and identify and deploy colleagues to their expertise

Preferred Experience:

  • Chronic, electronic implants
  • Gene therapy
  • Quality Engineering
  • Hosting audits for regulatory bodies and customers
  • Taking ownership of a medical device or pharmaceutical from ideation, development, submission, launch, and continuous improvement

Salary/Pay Range:

For individuals hired to work in California, Science is required by law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on geo-located salary bands. The base salary range for this full-time position is $100,000-$160,000 + equity + benefits. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers.

Benefits:

At Science, our benefits are in place to support the whole you:

  • Competitive salary and equity
  • Medical, dental, vision and life insurance
  • Flexible vacation and company-paid holidays
  • Healthy meals and snacks provided for non-remote employees
  • Paid parental, jury duty, bereavement, family care and medical leave
  • Dependent Care Flexible Spending Account, subsidized by Science
  • Flexible Spending Account
  • 401(k)

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local law.