Address
Form of workSenior Quality Systems Specialist
Palo Alto, CA
06 Months
Additional Role Description:
The role of Quality Assurance is to implement the applicable regulations and standards to products to assure safe and effective products get to the user. It is a supportive role involved in the whole product lifecycle from concept all the way through to post deployment.
Responsibilities:
Desired:
The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.
Palo Alto, CA
06 Months
Additional Role Description:
The role of Quality Assurance is to implement the applicable regulations and standards to products to assure safe and effective products get to the user. It is a supportive role involved in the whole product lifecycle from concept all the way through to post deployment.
Responsibilities:
- Provide Quality systems expertise toward the ongoing efforts for ISO 13485 Certification in Q3/4 - 2021
- Lead Auditor of the 21 CFR 820/ISO/MDR based quality management system for internal audits with a strong/working knowledge of Software as a Medical Device (SaMD) product development, deployment and maintenance
- Provide consulting and advisory services for design control and the software development life cycle process for SaMD
- Collaborate with key stakeholders in the creation and implementation of corporate level policies
- Collaborate, drive and support ongoing process improvement efforts, including implementation and maintenance of new quality systems.
- Provide support for other areas of the Quality Management System, as required.
- Bachelor's degree in a scientific discipline or equivalent practical experience.
- 7 - 10 years of experience in the Medical Device Industry associated with Class II or III devices.
- Experience with FDA 21 CFR 820, ISO 13485, IEC 62304, EU MDR, and other international regulations and standards.
- Must have experience with SaMD - Software as a Medical Device or medical devices with software integration.
Desired:
- Experience applying quality system regulations and standards to Software as a Medical Device (SaMD) and IEC 62304 highly preferred
- ASQ or ISO or MDSAP Certification(s).
- Excellent written and verbal communication skills.
The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.
