Director of Quality Assurance Software
Director of Quality Assurance Software
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$ 165000 - 195000
1 Vacancy
Job Description
Compensation: $165000 $195000 per year. You are eligible for a ShortTerm Incentive Plan with the target at 20 of your annual earnings; terms and conditions apply.
Director of Quality Software Hybrid in Aliso Viejo CA 23 days per week onsite) or Remote (PST)
The primary objective of this position is to lead and elevate our software quality assurance practices. This individual will be responsible for overseeing the development implementation and ongoing improvement of quality strategies for both internally developed and 3rd party software providing Quality Assurance and Regulatory oversight and ensuring compliance with all applicable regulations and incorporations of software industry best practices. This position will serve as a direct liaison between Information Technology Quality Assurance and stakeholders ensuring software and systems used by the business enable the delivery of high quality testing to our clients and patients. This role demands a proactive leader with a deep understanding of software development lifecycles testing methodologies and continuous improvement.
Essential Functions
- Lead Quality Assurance and software regulatory activities throughout the Software Development Lifecycle (SDLC) for new product development and maintenance initiatives including computer system implementation and validation projects managing multiple and complex projects
- Ensuring software development process is compliant with applicable standards regulations and guidance documents
- Drive and continuously improve our Quality Management System for software to ensure all design and development activity is fully compliant with appropriate applicable standards regulations and guidance documents
- Develop and deliver training for the software development Bioinformatics IT and other functions
- Provide expertise in establishing good software requirements specifications detailed design verification and validation protocols and planning documentation
- Review and/or approve requirements specifications product design documents validation protocols test plans test cases and other documentation as required and provide timely feedback
- Support the creation of necessary documentation to comply with regulatory requirements and industry best practices
- Establish and maintain software quality assurance processes procedures and controls to ensure compliance with appropriate regulatory requirements and standards
- Provide guidance on and participate in software development activities including design and code reviews requirements analysis and tracing defect tracking and configuration management
- Other duties as assigned
Qualifications
- 10 years of experience in software quality assurance with at least 5 years in a leadership or management role
- Bachelors degree or equivalent work experience in Computer Science Engineering or a related field (Masters preferred)
- Experience working with Software as a Medical Device or Software in a Medical device or In Vitro Diagnostic (IVD) or LDT
- Working knowledge of applicable regulations and procedures (e.g. IEC 62304 ISO 13485 CLIA FDA GxP and 21 CFR PART 11
- Strong analytical and problemsolving skills with exceptional attention to detail
- Excellent communication and interpersonal skills with the ability to influence stakeholders at all levels
- Experience with Agile SDLC tools such as Atlassian (JIRA Confluence and various plugins) and testing tools (TestRail Selenium Webdriver)
- Experience with continuous improvement projects
Preferred
- Masters degree in Computer Science Engineering or a related field
- Familiarity with cloud platforms (AWS preferred)
- Experience with a riskbased approach to validate Commercial off the Shelf (COTS) software and SW Tools
- Experience with electronic Quality Management Systems
#LISS1 #LIHYBRID
About Us:
Ambry Genetics Corporation is a CAPaccredited and CLIAlicensed molecular genetics laboratory based in Aliso Viejo California. We are a geneticsbased healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster.
At Ambry everyone is welcome. A career at Ambry Genetics is a chance to be part of a dynamic company that aims to improve health by understanding the relationships between genetics and human disease. We earned our reputation as industry leaders by responsibly introducing cuttingedge genetic testing solutions and continually sharing what we learn with the global scientific community.
At Ambry you will be learning challenging yourself and having fun while collaborating with teammates through the open exchange of outstanding benefits program includes 401k medical dental vision FSA paid sick leave and generous paid time off (PTO) program. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drugfree work environment.
The Company believes in second chance applicants with arrest or conviction history will be considered regardless of their arrest or conviction history consistent with local laws such as Los Angeles County Fair Chance Ordinance and the California Fair Chance do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check if the Company is concerned about conviction that is directly related to the job you will be given the chance to explain the circumstances surrounding the conviction provide mitigating evidence or challenge the accuracy of the background report. For the purpose of the above job description Essential Functions are Material Job Duties.
Our salary ranges are determined by role level and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range individual pay is determined by work location and additional factors including jobrelated skills experience and relevant education or training.
All qualified applicants will receive consideration for employment without regard to race (and traits historically associated with race including but not limited to hair texture and protective hairstyles such as braids locks and twists) color creed religion sex sexual orientation gender identity gender expression (including transgender status) national origin ancestry age marital status or protected veteran status and will not be discriminated against on the basis of disability protected medical condition as defined by applicable state or local law genetic information or any other characteristic protected by applicable federal state or local laws and ordinances. If you have a disability or special need that requires accommodation please contact us at
Ambry does not accept unsolicited resumes from individual recruiters third party recruiting agencies outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Ambry. Such resumes will be deemed the sole property of Ambry and will be processed accordingly.
PRIVACY NOTICES
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Required Experience:
Director
Employment Type
Full-Time
