The Staff Quality Engineer, Software will be the subject matter expert on providing guidance to the organization and the software teams in establishing policies and procedures for Software Design Control. This individual will be an integral part of the software development life cycle process in informing, guiding, and evaluating the teams' adherence to practices that would ensure compliance to required regulatory requirements.
SKILLS REQUIRED;
- Exp. with software med device design documents (i.e. software requirements, software design specifications, traceability matrix, verification and validation plan, unit level testing), FDA regulations, ISO 13485 and 14971
- Needs to understand lab developed tests (LDT) and associated instruments and software systems. HM does not prefer candidates whose device exp. is strictly with embedded products like pacemakers, pumps.
- Veeva QMS would be a very big plus
location: Menlo Park, California
job type: Contract
salary: $45 - 50 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Develop software development and software risk management policies and lead the activities associated with defining and maintaining software design control policies per required regulatory standards
- Provide subject expertise and input in the following areas: quality standards for software applications and systems that the company develops in support of the commercial product or quality processes
- Collaborate with software development teams, provide quality support, and facilitate the successful execution of the Software Design Control Process
- Responsible for Quality Engineering deliverables required within the product development process.
- Participate in new product development design review, design control, and related activities, regarding software systems
- Support Design Verification and Validation activities, including review of verification & validation protocols and reports.
- Assist in the analysis of product requirements and specifications. Participate in product design reviews and team meetings.
- Interface with all departments to provide leadership on the use of Quality Engineering methodologies, tools, regulatory compliance requirements.
- Provide technical guidance and training to other departments and quality personnel regarding software quality areas of expertise
- Support internal/supplier, partner audits and regulatory inspections of quality management functions, processes, and procedures with regards to software
- Support of other Quality Systems such as Corrective and Preventive Actions (CAPA), supplier corrective actions, and document control
qualifications:
- A minimum of BA/BS with 5+ years of Quality Engineering experience in an FDA regulated medical device manufacturing environment
- Advanced knowledge of, and proficiency with medical device development life cycles and Design Control processes
- Ability to handle complex issues and exercise judgement, based on experience, with minimal oversight from manager
- Knowledge of FDA QSR, ISO 13485, ISO 62304 and ISO 14971Software (Specific languages, test cases, SV&V) proficiency as well as software design and life cycle development experience/knowledge requiredAbility to plan and manage own work
- An aptitude for learning new platforms and technologies
skills: Data Analysis Software, Medical Device Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
