28 days old

Software Quality Manager

Myriad Genetics, Inc
South San Francisco, CA 94080
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  • Job Code
    129926492
Location: South San Francisco, CA, United States
Job Identification: 893
Job Schedule: Full time

DEPARTMENT: Quality Assurance / Regulatory Affairs
POSITION: Software QA Manager
POSITION REPORTS TO: Director, Quality Assurance
FLSA Status: Exempt

SUMMARY:
The Software Quality Manager is an enthusiastic, self-motivated person with great communication skills who can support the Quality Assurance program through building the software life cycle management program infrastructure as well as direct execution of software qualification and validation activities. The Software Quality Manager will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The candidate will be comfortable in a rapidly evolving Biotech environment assisting in the implementation of a value added QMS based on CLIA, CAP, NYS CLEP, ISO 13485, IEC 63204 and FDA QSR regulations.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Creating, updating, reviewing, and developing Software Life Cycle Management Program standard operating procedures and supporting work instructions based in CLIA, CAP, NYS CLEP, ISO 13485, IEC 62304 and FDA Quality System Regulations
Supporting training of personnel in requirements of quality tools and techniques, QMS based on ISO 13485/FDA 21 CFR 820 requirements, agile SW development process.
Designing validation strategies and methodologies for the qualification and validation of software utilizing an agile software development process.
Preparing, managing, and executing qualification, SW verification/validation protocols (e.g. CSV) in accordance with cGMP requirements
Implementation and support of technology transfer program (Change Control)
Supporting Change Control Board quality system/validation representation
Supporting Product Life Cycle/Development (PLC/NPD) quality/regulatory inputs for design and phase reviews
Training SW developers in design control and regulated software industry practices
Working around Production Department schedules to gain access to equipment/systems required for execution of validation protocols. May require performing critical validations on aggressive timetables.
Any and all other undefined tasks, as directed by your supervisor

REQUIREMENTS:
Minimum, B.S./B.A. in Computer Science, Engineering, Chemistry or Life Science. 3+ years as a Software Quality Manager or equivalent with experience in a medical device or clinical laboratory environment.
Experience with computerized system validation is required.
Working knowledge of regulated software standards and application: ISO 62304, GAMP 5 and risk management ISO 14971.
Developed and establish Automated testing processes.
Familiarity with modern software stacks.
Demonstrated knowledge of Risk Assessment Tools, Quality Statistics, Reliability Engineering, Six Sigma and Lean techniques and methodologies.
Experience in the development and maintenance of databases for tracking of quality system data and production defects.

Basic understanding of Bioinformatics as it pertains to DNA sequencing and genomics.

Experience in medical device/biotech start-up/fast growth company or similar working environment.

Working knowledge of cGMPs.

Advanced education, a plus.

Professional certification is highly preferred (e.g. ASQ CMQ/OE, CQE, CRE, or CSQE).

About UsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com .

WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Applicants and employees are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender,national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

Please answer all questions completely. Please do not provide any information not specifically requested on this Employment Application form.

PI129926492
Posted: 2021-02-05 Expires: 2021-03-09

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Software Quality Manager

Myriad Genetics, Inc
South San Francisco, CA 94080

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