Position:Senior Quality Engineer
Location:Redwood City, CA (Hybrid - 3 days onsite)
Length:6+ months
*W2 Candidates Only, No C2C
Job Description:
Our client is seeking a highly skilled Senior Quality Engineer to support ongoing product development and quality initiatives. This individual will be instrumental in ensuring compliance with regulatory standards (FDA, ISO, CLIA, CAP) for IVD product development and manufacturing. The ideal candidate will have strong experience in quality systems and product lifecycle processes and be capable of working cross-functionally to drive continuous improvement in a regulated environment.
Essential Duties and Responsibilities (but not limited to):
- Support quality activities related to reagent manufacturing processes and development efforts.
- Guide process controls, risk analyses, and validation strategies to ensure alignment with internal and regulatory standards.
- Review and approve manufacturing records; perform material disposition as required.
- Collaborate with cross-functional teams to ensure proper documentation and compliance in process validation and design transfer.
- Provide guidance on new product implementation, troubleshooting, and continuous improvement efforts.
- Lead and facilitate risk management activities and the change control process.
- Contribute to core quality system processes including document control, CAPA, training, and metrics development.
- Identify and pursue opportunities for process and quality improvements.
- Maintain organized, audit-ready documentation that demonstrates compliance with regulatory and internal requirements.
- Conduct internal audits and provide actionable feedback for remediation.
- Ensure safety and test quality concerns are appropriately escalated and documented.
Qualifications:
- Bachelor's degree in Chemistry, Biology, Engineering, or related scientific discipline.
- Minimum of 5 years of experience in quality assurance within FDA/ISO-regulated environments.
- Experience with molecular biology or molecular diagnostic products strongly preferred.
- Solid understanding of quality and regulatory standards including FDA 21 CFR 820, ISO 13485, and IVDR.
- Proficiency in statistical methods for process control, testing, and design experiments.
- Strong verbal and written communication skills, with the ability to collaborate across departments and organizational levels.
- Proven ability to manage multiple projects in a fast-paced, deadline-driven setting.
- Strong analytical thinking and problem-solving abilities.
- Comfortable working in both office and lab settings, with occasional exposure to biohazard materials and equipment.
- Pay range $130,000 - $145,000 depending on experience.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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- Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
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Digital Prospectors
Jun 24, 2025