POSITION SUMMARY:Quality Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The Quality Engineer works with QE Manager/QA Director to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations. This position will also represent QA on product development projects. Position will be hybrid with 1-3 days onsite a week.
PRIMARY RESPONSIBILITIES:- Support internal and external audits (CLIA/CAP, ISO 13485, customer)
- Responsible for CAPA, Deviation, Change Requests and Nonconformance investigation and reporting
- Write/revise procedures and forms; submit to Document Control and assist with training as needed
- Perform statistical analysis/hypotheses testing (AQL's etc) as required
- Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA
- Participate in the management of Approved Suppliers
- Follow established company standard operating procedures and good documentation practices
- Review manufacturing/QC batch records
- Other duties as assigned
QUALIFICATIONS:- Position requirements are a B.S. or equivalent in science, engineering or related field
- At least 6 years of experience in medical diagnostic, CLIA laboratory, or Life Sciences industry; 3 years experience in a quality role
- Audit experience - internal audits, third party audits and/or regulatory audits
- American Society of Quality certifications (CQE) preferred
KNOWLEDGE, SKILLS, AND ABILITIES:- Knowledge of CLIA/CAP regulations, ISO 13485 standard and/or FDA QSRs (21 CFR 820)
- 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: - Hands on experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc.
- 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
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.
Austin, TX
$94,300-$117,900 USD
