Quality Engineer (IVD, Pharma) Remote
- Austin, TX
Location: Austin, TX, San Carlos, CA or Remote, USA
Quality Engineer 3 supports the Natera quality management system. This position will be the QA representative on various new product development projects ensuring that the requirements for design controls are met from early to late stage development of CLIA assays and IVD products.
- Solve quality challenges and objectives in an effective, compliant and creative manner with minimal management oversight.
- Exercise good judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Is the Quality Representative on projects responsible for ensuring Design Control or Product and Production Control requirements are met per internal procedures and external requirements and standards.
- Provide guidance to team on risk management and quality engineering policies, principles and best practices.
- Facilitate and guide development and completion of risk management deliverables between systems by collaboratively working with teams such as R&D, Engineering, Marketing and Clinical teams.
- Create, revise and update laboratory, equipment, facility, HIPAA Privacy & Security and quality processes compliance.
- Develop and implement quality system and quality improvement programs.
- Primary lead for compliance activities (management of non-conformances, CAPA, environmental monitoring, process monitoring, audits, complaints investigations).
- Conduct or facilitate internal and external audits of product processes and recommend improvements (e.g. Notified Body, FDA, HIPAA).
- Participate in CAPA, Deviation, and Non-Conformance investigation and reporting.
- Lead Risk Assessments (e.g. FMEA, FTA, Risk Analysis) with cross-functional teams.
- Monitor and audit laboratory scientist's process workflow for compliance to HIPAA/ CLIA/ GMP/GLP/GCP and recommend updates.
- Participate in test method optimization, qualification, and validation as required.
- Perform quality assurance for sample testing in support of new products.
- Perform statistical analysis/hypotheses testing (AQL's etc.).
- Implement and monitor Statistical Process Control (SPC).
- Maintain Quality systems compliance to CLIA, FDA QSR, ISO 13485, GMP, GCP, GLP, and HIPAA.
- Participate in the management of Approved Suppliers.
- Record and review original test data and follow established company standard operating procedures and good documentation practices.
- Perform raw data and analytical testing review of in house and contract testing labs.
- Participate in laboratory maintenance activities, such as equipment maintenance and calibration status.
- Provide data policy and security industry expertise and advisory services to projects that involve healthcare data privacy regulations.
- Understand and apply applicable regulations and guidance from FDA QSRs, ISO13485, CLIA, GCP, ISO 14971, etc.
- Work as a member of a fully integrated team.
- This role works with PHI on a regular basis both in paper and electronic form and has 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.
- Other duties as assigned.
- B.S. in science, engineering, related field, or equivalent.
- Minimum of 5 years of experience in Quality process improvement in 21 CFR 820 QSR, SOR 98/282, IVDD, ISO13485, GMP/GLP/GCP/HIPAA environment with medical devices, CLIA laboratory, or Life Sciences industry.
- Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR, EN ISO 14971:2012, IEC 60601-1, ISO 13485, EN 62304, IEC 62366, FDA Guidance - Cyber Security, interoperability, assurance cases etc.) to the R&D environment.
- American Society of Quality certifications (CQE, CMQ/OE) or Six Sigma preferred.
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.
- Ability to be productive and successful in an intense work environment.
- Hands-on experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc. preferred.
- Demonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects preferred.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Duties typically performed in an office setting.
- Must be able to sit or stand for long periods of time.
Travel required for this position:
- No ☐ or Yes ☒ : If yes state anticipated percent for travel: up to 15%
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
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. Healthy catered lunches, Premium snacks and beverages, Onsite gym with cardio and weight-training equipment, Game room with satellite TV, Onsite dry cleaning and alteration service with pick-up and delivery, Employee-organized sport leagues, Happy hours and BBQs, 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.
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