Seran BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee ... Proficient with Microsoft Office Suite or related software Education and Experience * Bachelor ...
Seran BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee ... Proficient with Microsoft Office Suite or related software Education and Experience * Bachelor ...
The Software Quality Engineer II applies a wide variety for testing and quality assurance techniques to complex software projects often requiring coordination with multiple software delivery teams.
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The Software Quality Engineer II applies a wide variety for testing and quality assurance techniques to complex software projects often requiring coordination with multiple software delivery teams.
New
Associate Director of Quality Assurance, Operations
Bend, OR · On-site
$150 - $190/hr
Serán is seeking a QA Associate Director, who oversees the day‑to‑day operations of the Quality Assurance department with oversight of clinical manufacturing and warehouse activities in addition ...
Associate Director of Quality Assurance, Operations
Bend, OR · On-site
$150 - $190/hr
Serán is seeking a QA Associate Director, who oversees the day‑to‑day operations of the Quality Assurance department with oversight of clinical manufacturing and warehouse activities in addition ...
We're looking for an Associate Director, Quality Assurance (QA) Transformational Lead to champion a culture of continuous improvement by influencing cross-functional teams and stakeholders to embrace ...
We're looking for an Associate Director, Quality Assurance (QA) Transformational Lead to champion a culture of continuous improvement by influencing cross-functional teams and stakeholders to embrace ...
We'relooking for an Associate Director, Quality Assurance (QA) Transformational Lead tochampion a culture of continuous improvement by influencing cross-functional teams and stakeholders to embrace ...
We'relooking for an Associate Director, Quality Assurance (QA) Transformational Lead tochampion a culture of continuous improvement by influencing cross-functional teams and stakeholders to embrace ...
ServiceNow QA Analyst
OR · On-site +1
The ideal candidate combines a strong foundation in software quality assurance with excellent organization, communication, and attention to detail and is comfortable operating across both testing and ...
ServiceNow QA Analyst
OR · On-site +1
The ideal candidate combines a strong foundation in software quality assurance with excellent organization, communication, and attention to detail and is comfortable operating across both testing and ...
Serán is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to ...
Serán is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to ...
Seran is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to ...
Seran is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to ...
Serán is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to ...
Quick apply
Serán is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to ...
Serán is seeking a QA Associate Director, who oversees the day‑to‑day operations of the Quality Assurance department with oversight of clinical manufacturing and warehouse activities in addition ...
Serán is seeking a QA Associate Director, who oversees the day‑to‑day operations of the Quality Assurance department with oversight of clinical manufacturing and warehouse activities in addition ...
Required Experience • Excellent knowledge of mobile software QA processes and methodologies • 3-5 years of professional work experience in a software QA engineer role • Knowledge of XCode ...
Required Experience • Excellent knowledge of mobile software QA processes and methodologies • 3-5 years of professional work experience in a software QA engineer role • Knowledge of XCode ...
Application Development Project Management Quality Assurance Business/Systems Analysis ... Test Director, Bugzilla, Team Track, JIRA, TFS, etc.) * 1 year of experience in verifying the ...
Application Development Project Management Quality Assurance Business/Systems Analysis ... Test Director, Bugzilla, Team Track, JIRA, TFS, etc.) * 1 year of experience in verifying the ...
Fully Remote Quality Assurance Analyst 6/30/26
Portland, OR · Remote
$55 - $63/hr
Demonstrated experience in aligning QA strategy with software development activities and overall schedule while supporting the SDLC. Proficient in executing the test and validation activities of a ...
Quick apply
Fully Remote Quality Assurance Analyst 6/30/26
Portland, OR · Remote
$55 - $63/hr
Demonstrated experience in aligning QA strategy with software development activities and overall schedule while supporting the SDLC. Proficient in executing the test and validation activities of a ...
Fully Remote Quality Assurance Analyst 6/30/26
Portland, OR · On-site +1
$55 - $63/hr
Demonstrated experience in aligning QA strategy with software development activities and overall schedule while supporting the SDLC. Proficient in executing the test and validation activities of a ...
Fully Remote Quality Assurance Analyst 6/30/26
Portland, OR · On-site +1
$55 - $63/hr
Demonstrated experience in aligning QA strategy with software development activities and overall schedule while supporting the SDLC. Proficient in executing the test and validation activities of a ...
QA Engineer
OR · On-site +1
Have a good knowledge of software QA methodologies, tools, and processes. * Have a good understanding of testing integration, functional, end-to-end, and API tests (Postman). * Have experience with ...
QA Engineer
OR · On-site +1
Have a good knowledge of software QA methodologies, tools, and processes. * Have a good understanding of testing integration, functional, end-to-end, and API tests (Postman). * Have experience with ...
Quality Engineer III - Mobile
Beaverton, OR · On-site
$74K - $96K/yr
Perform or direct verification of software requirement allocations, traceability, and testability ... A processes and methodologies 3-5 years of professional work experience in a software QA engineer ...
Quality Engineer III - Mobile
Beaverton, OR · On-site
$74K - $96K/yr
Perform or direct verification of software requirement allocations, traceability, and testability ... A processes and methodologies 3-5 years of professional work experience in a software QA engineer ...
The Design Quality Assurance group (DQA) is looking for an experienced Principal Software Quality Assurance Engineer who is interested in using their technical skills and experience to improve ...
The Design Quality Assurance group (DQA) is looking for an experienced Principal Software Quality Assurance Engineer who is interested in using their technical skills and experience to improve ...
The Design Quality Assurance group (DQA) is looking for an experienced Principal Software Quality Assurance Engineer who is interested in using their technical skills and experience to improve ...
The Design Quality Assurance group (DQA) is looking for an experienced Principal Software Quality Assurance Engineer who is interested in using their technical skills and experience to improve ...
The Design Quality Assurance group (DQA) is looking for an experienced Principal Software Quality Assurance Engineer who is interested in using their technical skills and experience to improve ...
The Design Quality Assurance group (DQA) is looking for an experienced Principal Software Quality Assurance Engineer who is interested in using their technical skills and experience to improve ...
QA Analyst
Medford, OR · On-site
PLEXIS Healthcare Systems, Inc., a progressive software development company in Medford, OR, is looking to hire an enthusiastic and experienced QA Analyst . The candidate must be local to the Southern ...
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Quick apply
QA Analyst
Medford, OR · On-site
PLEXIS Healthcare Systems, Inc., a progressive software development company in Medford, OR, is looking to hire an enthusiastic and experienced QA Analyst . The candidate must be local to the Southern ...
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Software Qa Director information
See Oregon salary details
$59.7K - $76.2K
3% of jobs
$76.2K - $92.6K
9% of jobs
$108.1K is the 25th percentile. Wages below this are outliers.
$92.6K - $109K
14% of jobs
$109K - $125.5K
14% of jobs
$125.5K - $141.9K
10% of jobs
The median wage is $142.5K / yr.
$141.9K - $158.4K
14% of jobs
$171.9K is the 75th percentile. Wages above this are outliers.
$158.4K - $174.8K
14% of jobs
$174.8K - $191.2K
11% of jobs
$191.2K - $207.7K
6% of jobs
$207.7K - $224.1K
3% of jobs
$224.1K - $240.5K
2% of jobs
$59.7K
$148.1K
$240.5K
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Full-time
PTO
Re-posted 19 days ago
Job description
- Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
- Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review
- Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management
- Defines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programs
- Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie
- Provides Quality leadership and oversight of validation programs including:
- Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems
- Approval and oversight of validation lifecycle documentation including:
- Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reports
- Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan
- Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments
- Ensures validated systems maintain a continuous state of control throughout their operational lifecycle
- Supports the design and implementation of the organization's Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
- Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations
- Oversees validation lifecycle management for computerized systems including:
- Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systems
- Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
- Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
- Supports system lifecycle activities including system upgrades, migrations, and decommissioning
- Provides QA oversight and approval for quality system elements impacting validated systems including:
- Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments, & Periodic reviews of validated systems
- Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards
- Provides QA support for technology transfer, new product introductions, and site capital projects
- Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies
- Supports troubleshooting of complex process or system issues impacting validated systems
- Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits
- Leads preparation and inspection readiness programs related to validation and data integrity
- Leads and develops a high-performing Quality Engineering and CSA organization
- Provides mentoring, coaching, and professional development for technical staff
- Establish clear departmental goals aligned with organizational quality and operational objectives
- Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
- Fosters a culture of quality ownership, compliance, and continuous improvement
- Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
- Experience organizing and managing work responsibilities while working independently with minimal oversight
- Deep expertise in Computer System Validation / Computer System Assurance
- Validation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologies
- Time and project management skills with the ability to multi-task and meet deadlines
- Excellent verbal and written communication skills
- Excellent interpersonal and customer service skills
- Excellent organizational skills and attention to detail
- Strong analytical and problem-solving skills
- Strong supervisory and leadership skills
- Ability to prioritize tasks and to delegate them when appropriate
- Willingness to accept feedback from a variety of sources
- Ability to constructively manage conflict
- Ability to collaborate and work in cross-functional teams
- Ability to function well in a high-paced and at times stressful environment
- Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
- Proficient with Microsoft Office Suite or related software
- Bachelor's degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree
- Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
- Minimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacity
- Demonstrated experience with regulatory inspections by the FDA and EU authorities
- Prolonged periods of sitting or standing at a desk and working on a computer
- Must be able to lift up to 15 pounds at times
- Adheres to consistent and predictable in-person attendance
About Seran BioScience
Sourced by ZipRecruiter
Industry
Manufacturing
Company size
1 - 10 Employees
Headquarters location
Bend, OR, US
Year founded
2016