Director of QA/RA
Full time permanent
This position has primary responsibilities in quality assurance and regulatory compliance.
Essential Job Functions
- Complete test plans and RMF checklists for various standards in preparation for certification.
- Identify gaps in compliance and implement solutions to address gaps.
- Work directly with suppliers to plan, prepare for, and execute various verification testing.
- Provide documentation support for various design control documentation.
- Support CAPA and NCMR processes through investigation, implementation, and monitoring of effectiveness as required.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Monitor product quality through inspection, testing, and auditing.
- May be responsible for creating risk analyses and FMEAs.
- May draft or perform process validations as required by the Master Validation Plan.
- Other duties as assigned.
- Responsible for following the company’s quality management system and all applicable laws and regulations.
- Bachelor’s degree in engineering, life sciences or other applicable degree; Master’s degree preferred.
- Must have at least 5 years of experience in medical device quality assurance.
- Certification such as ASQ CQE preferred.
- Must have experience:
- IEC 60601-1 Electrical Safety
- IEC 60601-1-2 EMC
- ISO 14971 Risk Management
- 62366 and 60601-1-6 Usability Engineering.
- 62304 Software Life Cycle experience is preferred.
- Good working knowledge of quality systems and specific regulations (e.g., 21 CFR 820, ISO 13485).
- Proficiency with MS Office (Word, Excel, and PowerPoint) required.
- Knowledge and experience with eQMS software or other office/engineering software preferable.
- Must be organized, a strong communicator, detail-oriented, and cooperative in a fast-paced environment.
- Repetitive computer use required.
- Some travel (up to 25%) may be required.
- Follow lab and office safety standards
- Use personal protective equipment (PPE) as required in various work environments and with certain materials and equipment. Employees must use the appropriate PPE for the environment and/or task, e.g. laboratory, handling cryogenic materials, etc.
Job Type: Full-time
Pay: $90,000.00 - $110,000.00 per year
- Dental Insurance
- Health Insurance
- Life Insurance
- Paid Time Off
- Vision Insurance
Our employees work remotely as needed.
- 60601-1: 2 years (Preferred)
- ISO 13485: 3 years (Required)
- Mountain View, CA 94043 (Required)
- Only full-time employees eligible
- Temporarily due to COVID-19
Please mention that you come from TestForThem
when applying for this job.