POSITION SUMMARY:
Quality Engineer III supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The QE III 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.
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