1

Fda Jobs in Bothell, WA (NOW HIRING)

Maintain compliance with GMP, GxP, FDA, ISO, and regulatory standards * Travel to customer sites within assigned territory Equipment & Systems Supported * Refrigerators & freezers * Ultra-low ...

-->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 ...

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

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.

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

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

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

Showing results 41-60

Fda information

What qualifications do you need to work for the Food and Drug Administration?

To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or healthcare. Many positions require specialized knowledge, experience, or advanced degrees, and some roles may require professional certifications or licenses. Strong analytical skills, attention to detail, and familiarity with regulatory guidelines are also important.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What does an FDA professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood 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:

Infographic showing various Fda job openings in Bothell, WA as of August 2026, with employment types broken down into 64% Full Time, 13% Part Time, and 23% Contract. Highlights an 93% In-person, and 7% Remote job distribution.

Food Safety & Quality Assurance Specialist

Orca Bay Foods

Seattle, WA

Full-time

Re-posted 3 hours ago


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.