Whatsapp
Posted : Tuesday, March 12, 2024 03:46 PM
POSITION SUMMARY:
Quality Engineer I supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software.
The QE I works with senior level QE's to address Quality Events such as internal/external audits, non-conformances and corrective actions that impact the CLIA laboratory operations.
PRIMARY RESPONSIBILITIES: Serve as the administrator for CAPAs within the eQMS.
Facilitate the creation of CAPA records from both internal and external sources Coordinate and host routine CAPA Review Board meetings Collect and trend quality metrics for review by Management/Executive Leadership teams.
Create and host trainings to familiarize users with CAPA workflows and how to conduct effective Root Cause Analyses Act as an Internal Audit Coordinator to schedule internal audits and ensure they are conducted annually in accordance with all applicable regulatory requirements Act as lead and/or support auditor for internal audits, as appropriate Act as SME for CAPA and Audit processes during external audits.
Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA Follow established company standard operating procedures and good documentation practices QUALIFICATIONS: Position requirements are a B.
S.
or equivalent in science, engineering or related field At least 2-5 years experience in Quality process improvement in 21 CFR 820 QSR, medical diagnostic CLIA laboratory, or Life Sciences industry KNOWLEDGE, SKILLS, AND ABILITIES: Computer skills (MS Word, Excel, PowerPoint, etc.
) Good technical writing and communication skills Independent worker, a self-starter with strong organizational and planning skills Has an ability to be productive and successful in an intense work environment Preferred skills: Certified Quality Auditor Training (ISO-13485, FDA 21 CFR 820 QSR) The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
This may differ in other locations due to cost of labor considerations.
San Carlos, CA $1—$1 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health.
Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
When you join Natera, you'll work hard and grow quickly.
Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits.
Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more.
We also offer a generous employee referral program! For more information, visit www.
natera.
com.
Natera is proud to be an Equal Opportunity Employer.
We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.
Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.
We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.
natera.
com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.
com email domain ONLY.
Email communications from all other domain names are not from Natera or its employees and are fraudulent.
Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team.
Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information: - BBB announcement on job scams - FBI Cyber Crime resource page
The QE I works with senior level QE's to address Quality Events such as internal/external audits, non-conformances and corrective actions that impact the CLIA laboratory operations.
PRIMARY RESPONSIBILITIES: Serve as the administrator for CAPAs within the eQMS.
Facilitate the creation of CAPA records from both internal and external sources Coordinate and host routine CAPA Review Board meetings Collect and trend quality metrics for review by Management/Executive Leadership teams.
Create and host trainings to familiarize users with CAPA workflows and how to conduct effective Root Cause Analyses Act as an Internal Audit Coordinator to schedule internal audits and ensure they are conducted annually in accordance with all applicable regulatory requirements Act as lead and/or support auditor for internal audits, as appropriate Act as SME for CAPA and Audit processes during external audits.
Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA Follow established company standard operating procedures and good documentation practices QUALIFICATIONS: Position requirements are a B.
S.
or equivalent in science, engineering or related field At least 2-5 years experience in Quality process improvement in 21 CFR 820 QSR, medical diagnostic CLIA laboratory, or Life Sciences industry KNOWLEDGE, SKILLS, AND ABILITIES: Computer skills (MS Word, Excel, PowerPoint, etc.
) Good technical writing and communication skills Independent worker, a self-starter with strong organizational and planning skills Has an ability to be productive and successful in an intense work environment Preferred skills: Certified Quality Auditor Training (ISO-13485, FDA 21 CFR 820 QSR) The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
This may differ in other locations due to cost of labor considerations.
San Carlos, CA $1—$1 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health.
Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
When you join Natera, you'll work hard and grow quickly.
Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits.
Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more.
We also offer a generous employee referral program! For more information, visit www.
natera.
com.
Natera is proud to be an Equal Opportunity Employer.
We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.
Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.
We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.
natera.
com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.
com email domain ONLY.
Email communications from all other domain names are not from Natera or its employees and are fraudulent.
Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team.
Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information: - BBB announcement on job scams - FBI Cyber Crime resource page
• Phone : NA
• Location : San Carlos, CA
• Post ID: 9083916464
