Senior Quality Specialist - Remote - Invitae

About the position Responsibilities • Administer the electronic Quality Management System (Jira) for documenting quality management activities. • Work cross-functionally with team members and leaders to maintain and improve system performance. • Train and mentor subject matter experts in required elements and best practices of assigned Quality Programs. • Act as Quality Program subject matter expert supporting external audits. • Monitor, trend, analyze and report Quality Program data at Site Management Review meetings. • Provide recommendations for process and program improvements using lean six sigma methods. • Support Quality Lead and team with additional Quality Programs as necessary. Requirements • Bachelor's degree in a relevant scientific discipline or engineering with strong technical capability. • Minimum of 7 years of experience in Quality Assurance and/or Regulatory Affairs. • Experience in clinical diagnostic laboratory, medical device or related industry. • Experience managing or leading quality management programs with a solid understanding of processes. Nice-to-haves • Knowledge and/or experience with regulatory requirements including CLIA, NYSDOH and CAP. • Knowledge and/or experience with FDA regulations and ISO standards (e.g. QSR 820, ISO 13485 or ISO 15189). • Yellow or Green Belt in Lean Six Sigma. Benefits • Medical • Dental • Vision • Life • STD/LTD • 401(k) • Paid Time Off (PTO) or Flexible Time Off (FTO) • Tuition Reimbursement • Employee Stock Purchase Plan Apply tot his job Apply To this Job