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 Now
Apply Now
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 Now
Apply Now