Danaher Corporation Software Quality Engineer in Sunnyvale, California
ESSENTIAL JOB RESPONSIBILITIES:
Perform duties as an individual contributor and/or team member with 100% hands-on work
Define test architecture and strategy for complex and integrated systems
Coordinate and Participate in requirements development, configuration and change control, and Go/No-Go decisions.
Ability to update and author SOP
Write validation plans and reports
Understanding of Good Documentation Practices (GDP)
Create and Execute OQ and PQ protocols as needed
Guide users on validation of Macros/ Worksheets and aid in documenting them appropriately in the Inventory log.
Guide project team to write quality documents related to software validation and reviews for effectiveness
Guide project team's offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
Define validation schedule, engage stakeholders to seek agreement on deliverables and responsibilities
Coordinate and conduct risk analysis
Ability to review and provide key inputs to Design Input Requirements of complex manufacturing lines.
Create change orders in document control system
Review and approve change controls and other quality documents required to maintain the system in validated state
Participate in software supplier audits as needed
Maintains Non-product software inventory throughout the company
Participate in internal and external audits as a subject matter expert for computer systems
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
BA/BS degree or equivalent work experience in Computer Science, Biology, Biomedical, Electrical or related field.
A minimum 2 years of software testing experience in a regulated environment OR
Master's degree in field with 0-2 years experience
Knowledge and skills:
Must have completed several major computer systems projects (such as ERP, MES) with multiple release cycles and have working knowledge of software development lifecycle in FDA/ISO or other regulated field
Experience in cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks
Experience in leading resolution efforts when issues are identified and escalate appropriately
Experience in proactively identify and assist in prioritizing opportunities to streamline testing and/or quality but still stay compliant
Must have experience with: Windows environments, Excel Macros/Worksheets, and SQL or other RDBMS systems
Ability to provide key inputs to Design Input Requirements of complex manufacturing lines
Update Traceability matrices and quality metrics
Be knowledgeable in QSR and 21 CFR Part 11 regulations
Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products quickly
Able to lead small projects with manageable risks and resource requirements
Have strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction
Ability to work in different time zones and available to approve system go-live during scheduled customer downtimes (often occurs over the weekends).
Ability to work in office and lab environments
Ability to lift instruments that weigh up to 25 pounds
Experience with other applications such as defect tracking, web-based applications, requirements management
Experience working in a fast-paced environment while successfully working on multiple products simultaneously
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Equal Opportunity Employer
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .