Experience with HACCP, FDA regulations, GMPs, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement is highly desirable. Strong organizational, communication, and ...
Experience with HACCP, FDA regulations, GMPs, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement is highly desirable. Strong organizational, communication, and ...
The ideal candidate will have strong experience in supplier quality engineering, supplier audits, and manufacturing process improvements within FDA-regulated medical device environments. Key ...
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The ideal candidate will have strong experience in supplier quality engineering, supplier audits, and manufacturing process improvements within FDA-regulated medical device environments. Key ...
Field Calibration Technician - Seattle, WA
Renton, WA · On-site
$70K - $82K/yr
Maintain compliance with GMP, GxP, FDA, ISO, and regulatory standards * Travel to customer sites within assigned territory Equipment & Systems Supported * Refrigerators & freezers * Ultra-low ...
Field Calibration Technician - Seattle, WA
Renton, WA · On-site
$70K - $82K/yr
Maintain compliance with GMP, GxP, FDA, ISO, and regulatory standards * Travel to customer sites within assigned territory Equipment & Systems Supported * Refrigerators & freezers * Ultra-low ...
Maintain current knowledge of regulations and guidelines (e.g., ICH, FDA, EMA) and keep abreast of changes in the global regulatory environment. * Support regulatory inspections, as required.
Maintain current knowledge of regulations and guidelines (e.g., ICH, FDA, EMA) and keep abreast of changes in the global regulatory environment. * Support regulatory inspections, as required.
-->Package validation (L2)-V& V experience in Life Science Domain (FDA). -->Testing Concepts (L3)-Should be able to differentiate the different Testing phases like Unit Integration, System, Acceptance ...
-->Package validation (L2)-V& V experience in Life Science Domain (FDA). -->Testing Concepts (L3)-Should be able to differentiate the different Testing phases like Unit Integration, System, Acceptance ...
Clinical Medicine
Bellevue, WA · On-site
$20.25 - $25.75/hr
Support SAE review, safety narratives, aggregate safety assessments, unblinding procedures, and FDA safety reporting. * Participate in protocol development, investigator meetings, site training ...
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Clinical Medicine
Bellevue, WA · On-site
$20.25 - $25.75/hr
Support SAE review, safety narratives, aggregate safety assessments, unblinding procedures, and FDA safety reporting. * Participate in protocol development, investigator meetings, site training ...
Quality Engineer
Everett, WA · On-site
$79K - $102K/yr
Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers. Responsibilities: * Ensure appropriate document control process is in place as it relates to medical activities.
Quality Engineer
Everett, WA · On-site
$79K - $102K/yr
Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers. Responsibilities: * Ensure appropriate document control process is in place as it relates to medical activities.
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Food Safety & Quality Assurance Specialist
Seattle, WA · On-site
$72K - $85K/yr
Experience with HACCP, FDA regulations, GMPs, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement is highly desirable. Strong organizational, communication, and ...
Food Safety & Quality Assurance Specialist
Seattle, WA · On-site
$72K - $85K/yr
Experience with HACCP, FDA regulations, GMPs, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement is highly desirable. Strong organizational, communication, and ...
Represent Toxicology during FDA, EMA, PMDA, and other global health authority interactions. * Ensure nonclinical programs comply with ICH, FDA, EMA, OECD, and applicable global regulatory guidance.
Represent Toxicology during FDA, EMA, PMDA, and other global health authority interactions. * Ensure nonclinical programs comply with ICH, FDA, EMA, OECD, and applicable global regulatory guidance.
Ensure compliance with food safety and regulatory standards, including OSHA, FDA, USDA, and HACCP requirements. * Support Lean Manufacturing initiatives and identify opportunities to improve ...
New
Ensure compliance with food safety and regulatory standards, including OSHA, FDA, USDA, and HACCP requirements. * Support Lean Manufacturing initiatives and identify opportunities to improve ...
New
Quality Engineer
Everett, WA · On-site
$79K - $102K/yr
Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers. Responsibilities: * Ensure appropriate document control process is in place as it relates to medical activities.
Quality Engineer
Everett, WA · On-site
$79K - $102K/yr
Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers. Responsibilities: * Ensure appropriate document control process is in place as it relates to medical activities.
Cybersecurity Engineer
Bothell, WA · On-site
$147.54 - $182/hr
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Cybersecurity Engineer
Bothell, WA · On-site
$147.54 - $182/hr
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Food Safety & Quality Assurance Specialist
$72K - $85K/yr
Experience with HACCP, FDA regulations, GMPs, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement is highly desirable. Strong organizational, communication, and ...
Quick apply
Food Safety & Quality Assurance Specialist
$72K - $85K/yr
Experience with HACCP, FDA regulations, GMPs, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement is highly desirable. Strong organizational, communication, and ...
Our flagship product, PROVENGE (sipuleucel-T) , was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the disease.
Our flagship product, PROVENGE (sipuleucel-T) , was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the disease.
Cybersecurity Engineer
Bothell, WA · On-site
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Cybersecurity Engineer
Bothell, WA · On-site
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Our flagship product, PROVENGE ® (sipuleucel-T) , was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the ...
Our flagship product, PROVENGE ® (sipuleucel-T) , was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the ...
Cybersecurity Engineer
Bothell, WA · On-site
$148 - $182/hr
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Cybersecurity Engineer
Bothell, WA · On-site
$148 - $182/hr
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Cybersecurity Engineer
Bothell, WA · On-site
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Cybersecurity Engineer
Bothell, WA · On-site
Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96); define verification strategies specifying required evidence, timing, and ownership
Key Account Manager - Seattle
Seattle, WA · On-site
Our flagship product, PROVENGE ® (sipuleucel-T) , was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the ...
Key Account Manager - Seattle
Seattle, WA · On-site
Our flagship product, PROVENGE ® (sipuleucel-T) , was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the ...
Fda information
What qualifications do you need to work for the Food and Drug Administration?
What are some typical challenges faced by professionals working at the FDA, and how can they be managed?
What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?
What does an FDA professional do?
What is the difference between Fda vs Food Scientist?
| Aspect | Fda | Food Scientist |
|---|---|---|
| Required Credentials | Typically a degree in health, science, or related field; certifications vary | Bachelor's or master's in food science, microbiology, or related |
| Work Environment | Regulatory agencies, laboratories, inspection sites | Food manufacturing facilities, laboratories, research settings |
| Employer & Industry Usage | U.S. Food and Drug Administration, government agencies | Food companies, research institutions, government agencies |
| Common Search & Comparison Intent | Understanding regulatory roles, compliance, and enforcement | Food safety, product development, research |
While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.
What are popular job titles related to Fda jobs in Bothell, WA?
For Fda jobs in Bothell, WA, the most frequently searched job titles are:
What job categories do people searching Fda jobs in Bothell, WA look for?
The top searched job categories for Fda jobs in Bothell, WA are:
What cities near Bothell, WA are hiring for Fda jobs?
Cities near Bothell, WA with the most Fda job openings:

Job description
Orca Bay Foods is seeking a Food Safety & Quality Assurance Specialist to support food safety, quality assurance, regulatory compliance, and audit readiness at our seafood manufacturing facility in Seattle. This role plays a key part in ensuring products consistently meet customer specifications, regulatory requirements, and company standards while promoting a culture of food safety, quality, and continuous improvement throughout the organization.
The Food Safety & Quality Assurance Specialist supports the implementation and maintenance of HACCP, GMP, sanitation, environmental monitoring, product quality, and regulatory compliance programs. This position assists with customer, third-party, social responsibility, and regulatory audits, including SQF, BAP, SMETA, Costco Social Compliance, customer audits, and regulatory inspections. Working collaboratively with Operations, Sanitation, Maintenance, Human Resources, and Corporate Quality, the Specialist helps maintain compliance, investigate quality concerns, implement corrective actions, and ensure the facility remains audit-ready.
The ideal candidate will have 3-5 years of experience in food manufacturing, seafood processing, or a related FDA-regulated environment, with a strong understanding of food safety systems, quality assurance, and regulatory compliance. Experience with HACCP, FDA regulations, GMPs, root cause analysis, corrective and preventive actions (CAPA), and continuous improvement is highly desirable. Strong organizational, communication, and problem-solving skills are essential. This position is based in Seattle and requires regular on-site presence.
Key Responsibilities- Support the implementation and maintenance of facility food safety and quality assurance programs.
- Maintain compliance with HACCP, Seafood HACCP, GMPs, SSOPs, SQF, BAP, SMETA, Costco Social Compliance, and applicable regulatory and customer requirements.
- Assist with customer, third-party, and regulatory audits by preparing documentation, participating in inspections, and tracking corrective actions through completion.
- Investigate product quality issues, customer complaints, non-conformances, and food safety concerns, and assist with root cause analysis and corrective and preventive actions.
- Maintain accurate, organized, and audit-ready food safety, quality, and compliance documentation.
- Partner with Operations, Sanitation, Maintenance, Human Resources, and Corporate Quality to support compliance initiatives and continuous improvement efforts.
- Monitor environmental, sanitation, and quality data, identify trends, and recommend corrective or preventive actions.
- Assist with employee training on HACCP, GMPs, food safety practices, quality systems, and regulatory requirements.
- Support product inspections, process verification, environmental monitoring, and other quality assurance activities as assigned.
Join a growing seafood industry leader committed to delivering safe, high-quality products while maintaining the highest standards of food safety, quality, regulatory compliance, and social responsibility. As a Food Safety & Quality Assurance Specialist, you will play an important role in protecting our products, supporting certification programs, and driving continuous improvement across the organization.
Education/Experience:
- Bachelor's degree in Food Science, Microbiology, Biology, Quality Assurance, or related field preferred.
- 2+ years of food safety or quality assurance experience in food manufacturing, seafood processing, or related industries.
- Strong knowledge of HACCP, FDA regulations, SQF, BAP, GMPs, sanitation programs, and food safety systems.
- Experience leading customer, regulatory, and third-party audits.
- HACCP Certification required or ability to obtain; SQF Practitioner and PCQI certifications preferred.
- Strong leadership, communication, problem-solving, and organizational skills.
Required Skills:
- Intermediate proficiency with MS office applications, specifically, Excel.
- Working knowledge and experience with ESHA Genesis R&D is strongly preferred.
- Familiarity with 3rd party web data sites.
- Excellent organizational skills
- Food industry-specific knowledge of ingredients, food allergens, ingredient functionality and product formulas.
- Experience working with and current understanding of nutrition, labeling, and regulatory concepts gained through technical reading, industry interaction, and/or attendance at appropriate seminars and educational courses.
Certificates, Licenses, Registrations:
HACCP, PCQI and SQF Certifications preferred.
About Orca Bay Foods
Sourced by ZipRecruiter
Industry
Food and drink manufacturing
Company size
201 - 500 Employees
Headquarters location
Seattle, WA, US
Year founded
1985