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Sr. Quality Systems Specialist

Redwood City, California
3 Sep 2022

The Role & The Team

Reporting to the Sr. Director Quality, they are seeking one exceptional Sr Quality Systems Specialist to join their Quality team. In this Cross-functional quality role, you will actively participate in the development and maintenance of this company's Quality Management System.

You will be responsible for the development of core quality systems processes (e.g., CAPA, Validation) and guiding teams through the execution of those core quality systems processes. In addition, you will be executing internal audits to assure adherence to applicable standards and industry best practices.

The ideal candidate will have a track record of accomplishments in the life sciences, pharmaceutical and/or biotechnology industry. The successful candidate is likely to have a background in medical device/life sciences with 5 to 8 years of experience in Quality. This role requires strong leadership skills.

Responsibilities & Goals

Areas of specific responsibility and attention will include:

  • Develops and maintains the Quality Systems, CAPA, Documentation, Training, Internal Audits and Change Controls Processes.
  • Evaluates, designs, implements, and continually improves the quality system processes to achieve quality goals and to maintain a high level of quality systems compliance.
  • Manages and performs quality systems audits.
  • Manage the systems to track and regularly report to management on the quality related KPI's. Establish action plans for quality KPI's not meeting goal.
  • Identify opportunities for improvement regarding compliance to applicable industry standards and regulations. (i.e. US FD&C, 21CFR11, 21CFR820; EN ISO 13485; EN ISO 14971; Etc.).
  • Provides effective leadership in teamwork development, effective communication, and quick responses to Customers.
  • Support issue resolution using a risk-based approach.
  • Supports the coordination of the external audits/inspections preparation and support and/or participate during external audits, as required.
  • Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.

Background & Qualifications

The successful candidate for the position of Sr. Quality Systems Engineer must have a demonstrated record of accomplishments in the life sciences industry. The ideal candidate will have had significant experience in building and maintaining quality systems processes. Candidates must bring a strong entrepreneurial orientation along with teamwork skills and an absolute commitment to competing with the highest level of integrity.

Key requirements include:

  • Bachelor's degree in Engineering or Science degree.
  • 5 to 8 years' experience in the Life Sciences Industry and/or in a regulated environment.
  • Prior hands-on experience in development and maintenance of quality systems processes.
  • Thorough knowledge of ISO13485, Quality System Regulations and medical device standards (US and EU).
  • Strong written and oral communication skills, with demonstrated experience in cross-functional and timely communication.
  • Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Seer's scientific and business goals.
  • Must work well in a small team setting, with the ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment.
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  • Job Reference: 703138792-2
  • Date Posted: 3 September 2022
  • Recruiter: Kapia Partners
  • Location: Redwood City, California
  • Salary: On Application