What are the responsibilities and job description for the Director of Quality Assurance (Software) position at Ambry Genetics?
Compensation: $165,000 - $195,000 per year. You are eligible for a Short-Term Incentive Plan with the target at 20% of your annual earnings; terms and conditions apply.
Director of Quality, Software - Hybrid in Aliso Viejo, CA (2-3 days per week on-site) 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
Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based 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 cutting-edge 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 ideas. Our 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 drug-free work environment.
The Company believes in second chance employment. Qualified 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 Act. You 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 job-related 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 careers@ambrygen.com
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
To review Ambry’s Privacy Notice, Click here: https://www.ambrygen.com/legal/privacy-policy
To review the California privacy notice, click here: California Privacy Notice | Ambry Genetics
To review the UKG privacy notice, click here: California Privacy Notice | UKG
Director of Quality, Software - Hybrid in Aliso Viejo, CA (2-3 days per week on-site) 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
- 10 years of experience in software quality assurance, with at least 5 years in a leadership or management role
- Bachelor's degree or equivalent work experience in Computer Science, Engineering, or a related field (Master’s 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 problem-solving 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 plug-ins) and testing tools (TestRail, Selenium Webdriver)
- Experience with continuous improvement projects
- Master’s degree in Computer Science, Engineering, or a related field
- Familiarity with cloud platforms (AWS preferred)
- Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW Tools
- Experience with electronic Quality Management Systems
Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based 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 cutting-edge 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 ideas. Our 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 drug-free work environment.
The Company believes in second chance employment. Qualified 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 Act. You 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 job-related 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 careers@ambrygen.com
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
To review Ambry’s Privacy Notice, Click here: https://www.ambrygen.com/legal/privacy-policy
To review the California privacy notice, click here: California Privacy Notice | Ambry Genetics
To review the UKG privacy notice, click here: California Privacy Notice | UKG
Salary : $165,000 - $195,000
