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Fda Openings Jobs in Bothell, WA (NOW HIRING)

TMS Health Education

Psychiatrist - Seattle

Seattle, WA · On-site

$300 - $360/hr

Esketamine is an FDA-approved prescription nasal spray for patients with treatment-resistant ... Track record of open partnership and effective collaboration within a multi-disciplinary team.

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Fda Openings information

What are the key skills and qualifications needed to thrive in FDA job openings, and why are they important?

To thrive in FDA job openings, candidates typically need a strong background in science, regulatory affairs, and analytical skills, often with a relevant degree in biology, chemistry, pharmacy, or related fields. Familiarity with regulatory databases, submission systems (such as eCTD), and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, effective communication, and the ability to work collaboratively are essential soft skills for success. These competencies ensure regulatory compliance, thorough review of submissions, and effective teamwork in safeguarding public health.

What are some common challenges faced by professionals starting in FDA roles, and how can applicants prepare for them?

Professionals beginning their careers at the FDA often encounter challenges such as adapting to complex regulatory frameworks, working with cross-disciplinary teams, and managing the pace of policy changes. To prepare, applicants should familiarize themselves with FDA guidelines and regulatory processes, develop strong communication skills to collaborate effectively with scientists, regulators, and industry representatives, and stay updated on current public health issues. Proactive learning and seeking mentorship within the organization can also ease the transition and foster professional growth.

What are FDA openings?

FDA openings refer to job opportunities or vacancies at the U.S. Food and Drug Administration (FDA). The FDA is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other related products. These openings span a wide range of roles, including scientists, inspectors, analysts, administrative professionals, and more. Candidates can find current job listings and application instructions on the official USAJOBS website and the FDA’s careers page. Working at the FDA offers the chance to contribute to public health and safety at a national level.
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Fda Openings jobs near you

Senior Supplier Quality Engineer

Stark Pharma Solutions Inc

Bothell, WA • On-site

Contractor

Re-posted 25 days ago

Job description

Hi,

My name is Karthik Mutyala and I’m a Recruitment Manager with Stark Pharma, specializing in pharmaceutical, biotechnology, and medical device roles. I came across your profile and wanted to see if you are open to new opportunities.

If interested, please send me your updated resume along with the best number and time to reach you.

Job Title: Senior Supplier Quality Engineer

Location: Bothell, WA (100% Onsite)

Duration: 6+ Month Contract

Job Summary

We are seeking a Senior Supplier Quality Engineer to support supplier quality operations within a medical device manufacturing environment. This role will focus on driving supplier quality improvements, resolving non-conformance issues, and ensuring compliance with regulatory and quality standards across the supply chain.

The ideal candidate will have strong experience in supplier quality engineering, supplier audits, and manufacturing process improvements within FDA-regulated medical device environments.

Key Responsibilities

  • Investigate, resolve, and prevent supplier-related non-conformances impacting manufacturing operations
  • Drive supplier corrective and preventive actions to improve product quality and process performance
  • Support implementation of design and manufacturing process changes at supplier sites
  • Conduct and document part qualification and process validation activities
  • Partner cross-functionally with Engineering, Manufacturing, Supply Chain, and Quality teams to prevent supplier-driven shortages and quality issues
  • Lead supplier quality system and process audits to ensure compliance with company and regulatory requirements
  • Monitor supplier performance metrics and identify opportunities for continuous improvement
  • Support evaluation, qualification, and onboarding of new suppliers
  • Participate in departmental meetings, training sessions, and continuous improvement initiatives

Required Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or related technical field
  • Minimum 5+ years of experience in Supplier Quality, Quality Engineering, or related roles within the medical device industry
  • Strong knowledge of FDA 21 CFR Part 820 and ISO 13485:2016 requirements
  • Experience conducting supplier audits and managing supplier quality systems
  • Strong communication, documentation, and problem-solving skills
  • Excellent organizational skills and attention to detail

If you are not interested, please feel free to refer your friends or colleagues who may be looking for an opportunity.