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Director Quality Engineer Fda Jobs in Oregon (NOW HIRING)

Trillium-Engineering

Quality Engineer

Hood River, OR · On-site

$75 - $105/hr

Quality Engineer Full Time Professional Hood River, OR, US Purpose of Position: The Quality ... Self-starter with a strong work ethic, able to work without direct supervision. Disclaimer: The ...

Ascentec Engineering

Quality Engineer

Tualatin, OR · On-site

$80K - $100K/yr

Ascentec Engineering is seeking a Quality Engineer to support our Machining and Integrated Assembly ... Own, direct and establish metrics for Supplier Quality Management * Makes the final decision on ...

Ascentec Engineering LLC

Quality Engineer

Tualatin, OR · On-site

$80K - $100K/yr

Description Ascentec Engineering is seeking a Quality Engineer to support our Machining and ... Own, direct and establish metrics for Supplier Quality Management * Makes the final decision on ...

Ascentec Engineering, LLC

Quality Engineer

Tualatin, OR · On-site

$80K - $100K/yr

Description: Ascentec Engineering is seeking a Quality Engineer to support our Machining and ... Own, direct and establish metrics for Supplier Quality Management * Makes the final decision on ...

MANSCAPED

Director, Quality & Regulatory

OR · On-site +1

... a Director, Quality & Regulatory responsible for ensuring that our products are safe, compliant ... Bachelor's degree in engineering, quality, manufacturing, regulatory affairs or related business ...

MWH

Quality Engineer

Gresham, OR · On-site

$76K - $98K/yr

The QC Engineer role also involves regular interaction across internal teams to support quality ... Director on a daily basis. * Proficient with some of the following: BIM / VDC Construction ...

MWH

Quality Engineer

Gresham, OR

$76K - $98K/yr

The QC Engineer role also involves regular interaction across internal teams to support quality ... Director on a daily basis. * Proficient with some of the following: BIM / VDC Construction ...

Selmet

Principal Quality Engineer

Albany, OR · On-site

Quality Engineer - Aerospace Manufacturing If you would love to be part of a company that is poised ... Will have direct responsibility of critical QMS processes as required per AS9100, AS13100, or other ...

Selmet

Manufacturing Quality Engineer

Albany, OR · On-site

$74K - $95K/yr

Quality Engineer - Aerospace Manufacturing If you would love to be part of a company that is poised ... Will have direct responsibility of critical QMS processes as required per AS9100, AS13100, or other ...

Selmet

Manufacturing Quality Engineer

Albany, OR · On-site

$74K - $95K/yr

Quality Engineer - Aerospace Manufacturing If you would love to be part of a company that is poised ... Will have direct responsibility of critical QMS processes as required per AS9100, AS13100, or other ...

Selmet

Manufacturing Quality Engineer

Albany, OR · On-site

$74K - $95K/yr

Quality Engineer - Aerospace Manufacturing If you would love to be part of a company that is poised ... Will have direct responsibility of critical QMS processes as required per AS9100, AS13100, or other ...

Selmet

Principal Quality Engineer

Albany, OR · On-site

Quality Engineer - Aerospace Manufacturing If you would love to be part of a company that is poised ... Will have direct responsibility of critical QMS processes as required per AS9100, AS13100, or other ...

Selmet

Principal Quality Engineer

Albany, OR · On-site

Quality Engineer - Aerospace Manufacturing If you would love to be part of a company that is poised ... Will have direct responsibility of critical QMS processes as required per AS9100, AS13100, or other ...

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All JobsQuality Engineer Fda JobsDirector Quality Engineer Fda JobsDirector Quality Engineer Fda Jobs in Oregon

Director Quality Engineer Fda information

What is the difference between Director Quality Engineer Fda vs Quality Engineer Fda?

AspectDirector Quality Engineer FdaQuality Engineer Fda
CredentialsTypically requires a Bachelor's degree in Engineering or Life Sciences, with certifications like ASQ CQE or ISO auditorRequires similar degrees and certifications, often entry to mid-level
Work EnvironmentLeads quality teams, oversees compliance, and strategic planning in manufacturing or biotech settingsPerforms hands-on quality testing, inspections, and process improvements
Industry UsageCommonly used in regulated industries like pharmaceuticals, biotech, and medical devicesUsed across manufacturing, biotech, and pharmaceutical companies for quality assurance

The main difference is that the Director Quality Engineer Fda holds a leadership role with strategic responsibilities, overseeing quality systems and compliance, while the Quality Engineer Fda focuses on operational quality tasks and testing. Both roles require similar credentials but differ in scope and seniority.

What are the most commonly searched types of Quality Engineer Fda jobs in Oregon?

The most popular types of Quality Engineer Fda jobs in Oregon are:

What are popular job titles related to Director Quality Engineer Fda jobs in Oregon?

For Director Quality Engineer Fda jobs in Oregon, the most frequently searched job titles are:

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Cities in Oregon with the most Director Quality Engineer Fda job openings:

Director Quality Engineer Fda jobs near you
Infographic showing various Director Quality Engineer Fda job openings in Oregon as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, 5% Contract, and 1% Nights. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution.

Director, Quality Engineering & Computer System Assurance

Seran BioScience

Bend, OR

Full-time

PTO

Re-posted 19 days ago

Job description

Seran BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization's validation, qualification, and computerized systems assurance programs.  This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.
 
This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.
 
The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.
Duties and Responsibilities
Strategic Leadership
  • 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
Validation Lifecycle Oversight
  • Provides Quality leadership and oversight of validation programs including:
    • Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems
Key activities include:
  • 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
Computer System Assurance (CSA) & Data Integrity
  • 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
Operational Quality Engineering Support
  • 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
Leadership & People Management
  • 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
Required Knowledge and Skills
  • 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
Education and Experience
  • 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
Physical Requirements
  • 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 
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
 
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
 
Benefits Summary:
Seran employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Seran covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.
 
The Corporate Headquarters of Seran BioScience are located at 63047 Layton Ave, Bend, OR 97701
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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