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Mgr, Quality Assurance

Natera

Natera

Quality Assurance
San Carlos, CA, USA
Posted on Thursday, May 30, 2024

POSITION SUMMARY:

Manager, Quality Assurance is responsible for supporting the quality management system, compliant with CAP, CLIA, NYS DoH, 21 CFR Part 820, and ISO 13485. This position tracks quality performance and makes decisions concerning quality issues by working directly with cross-functional teams. This position works closely with the Clinical Laboratory Director to ensure patient safety, and ensure the highest quality products are produced.

PRIMARY RESPONSIBILITIES:

  • Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions.

  • Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.

  • Manage and lead Quality team to support Natera’s Quality System processes. Provides leadership and direction directly or through teams as appropriate.

  • Responsible for developing, managing, maintaining, reporting, and improving quality metrics. Evaluate metrics to determine if quality problems exist and set the appropriate action and escalation.

  • Provide effective Quality Management leadership to department staff in order to meet quality, business, and organizational objectives.

  • Assess and build organizational capability for Quality.

  • Drive a culture of compliance within the team and cross functionally utilizing Natera Values.

  • Evaluate, implement. and continuously improve execution of Quality Systems and business processes, including product controls to achieve quality goals and maintain Regulatory Compliance.

  • Responsible for leading quality team in the management of Supplier Quality activities for Natera. This includes compliance to applicable regulations and standards for medical devices, in vitro diagnostics, biologics or companion diagnostics.

  • Responsible for all aspects of the Supplier Quality including but not limited to maintaining and improving processes for supplier qualification, monitoring of supplier performance, management of supplier issues, supplier audits, etc.

  • Act as Subject Matter Expert (SME) in the quality processes in the area of responsibility.

  • Mentor and develop personnel, including dedicated succession planning and contingency management. Ensure CAPA’s are implemented effectively and timely with a focus on reduction of customer complaints, non-conformances, rejections, and scrap.

  • Assist on identification of root cause of quality problems in Operations, Manufacturing or customer complaints.

  • Provide support and direction for new products, processes and Engineering Changes.

  • Oversee the product release to ensure that safe and effective product is distributed to customers. Responsible for approval or rejection of components, finished products, and documents to achieve this purpose.

  • May act as “management representative” for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution.

  • Document, review, and approve quality system documentations.

  • Working knowledge of CAP/CLIA, ISO 13485 and FDA, EU, ROW (rest of world) LDT and medical diagnostic requirements.

  • Direct Quality Assurance projects through the Leadership Team to sustain regulatory compliance and support company goals/continuous improvement efforts.

  • Assure that all quality department associates are trained to adequately perform their assigned quality responsibilities.

  • Comply with all local, state, and federal safety regulations, policies, and procedures including, if needed, Hazardous waste or safety regulations.

  • Comply with all quality policies, procedures, and practices through consistent application of sound quality assurance principles.

  • Other duties as assigned.

  • This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job.

  • Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

  • Must maintain a current status on Natera training requirements.

  • Employee must pass post offer criminal background check.

QUALIFICATIONS:

  • Typically requires a minimum of a Bachelor's degree in science, engineering, other relevant discipline, or equivalent.

  • A minimum of 3 years of supervisory experience or equivalent.

  • A minimum of 5 years of experience working in a CLIA LDT, Medical Device, IVD, Pharmaceutical or Biotech firm.

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Experienced with medical devices, and/or in vitro diagnostics, biologics, companion diagnostics or pharmaceuticals.

  • Prior medical device experience is a plus.

  • Experience leading a team in Quality is a plus.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

  • Travel – Approximately 15% of work time will be spent travelling

  • Duties are typically performed in an office setting.

  • This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.

  • Duties may require working outside normal working hours (evenings and weekends) at times.

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