Quality Assurance Operations Specialist
2 weeks ago
At Cepheid, we are dedicated to enhancing healthcare through rapid and precise diagnostic testing. Our mission propels us to develop scalable, innovative solutions that tackle the world's most intricate health challenges.
Our team members engage in every phase of molecular diagnostics, from conception to the development and delivery of testing advancements that enhance patient outcomes across various environments.
As part of our organization, you can create an immediate and measurable impact on a global scale, within a culture that promotes career advancement and personal growth.
Role OverviewThe Quality Operations Engineer plays a pivotal role in influencing the technical application of quality systems management within manufacturing, ensuring adherence to corporate policies, regulatory standards, and applicable guidelines.
This position is integral to the Lodi Quality Organization, focusing on continuous improvement to guarantee product consistency and reliability for ongoing operations.
Key Responsibilities- Act as a liaison for Quality, offering guidance to cross-functional teams for problem-solving, nonconformity investigations, risk mitigation, and change control that align with established requirements.
- Develop, track, and monitor project compliance with Design Controls and change control throughout the project lifecycle, ensuring consistency, reliability, robustness, and manufacturability of our products.
- Validate production and process controls through process validation, development of process control plans, and support of statistical process control within operations.
- Proactively identify potential gaps within the quality system and operational processes, collaborating to drive continuous improvement and informed decision-making utilizing quality tools such as CAPA and SCAR.
Applicants should possess a Bachelor's degree in an engineering discipline with 0-2 years of relevant experience. Candidates must demonstrate the ability to apply production and process controls, including process validation and statistical process control, in a manufacturing setting.
Experience in risk management processes (sFMEA, pFMEAs, dFMEAs, etc.) is essential, along with the ability to work effectively in a team environment and foster strong working relationships that value diversity and inclusion.
Preferred QualificationsPrevious experience in the medical device industry, familiarity with CFR 21 Part 820 (QSR), and ISO 13485 is advantageous. Additionally, experience with macro-development and a quality engineering certification from the American Society for Quality (ASQ) or other recognized organizations would be beneficial.
Compensation and BenefitsCepheid, a Danaher company, offers a comprehensive benefits package that enhances our employees' lives, including health care programs and paid time off. The salary range for this role is between $59,500 and $81,800, reflecting our good faith belief in the potential compensation for this position at the time of posting. This range may be adjusted in the future.
We provide a robust benefits package, including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees.
Commitment to DiversityAt Danaher, we unite science, technology, and operational capabilities to accelerate the real-life impact of tomorrow's innovations. We are committed to equal opportunity, valuing diversity in our workforce and the markets we serve.
We ensure that individuals with disabilities receive reasonable accommodations to participate in the job application or interview process, perform essential job functions, and access other employment benefits.
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