Quality Engineer

Reposted 11 Hours Ago
Be an Early Applicant
Timonium, MD, USA
In-Office
75K-120K Annually
Senior level
Biotech
The Role
The Quality Engineer ensures Quality Assurance and Control activities, investigates customer complaints, supports CAPA resolutions, and maintains compliance with Quality Management Systems in manufacturing.
Summary Generated by Built In

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Pall Corporation, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety and environmentally responsible technologies. From airplane engines to hydraulic systems, scotch to smartphones, OLED screens to paper—everyday Pall is there, helping protect critical operating assets, improve product quality, minimize emissions and waste, and safeguard health. For the exponentially curious, Pall is a place where you can thrive and amplify your impact on the world. Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation.

Learn about the Danaher Business System which makes everything possible.

The Quality Engineer is responsible for Quality Assurance & Quality Control activities supporting quality, production, and process requirements for Pall Corporation Timonium. This includes product and process support starting from review of customer requirements, insuring flow down into drawings, routers, and purchase orders, to final shipment of product to customer and aftermarket support.

This position reports to the Quality Manager and is part of the Quality Assurance department located in Timonium, Maryland. This is an on-site role.

In this role, you will have the opportunity to:

  • Lead and coordinate customer quality complaint investigations, partnering closely with the manufacturing plant to perform structured root‑cause analysis (e.g., 8D, Fishbone diagram, FMEA, Pareto Analysis) and drive effective and on-time delivery CAPA resolution.
  • Drive daily management and problem‑solving activities within the manufacturing environment, to address process deviations, defects, and improvement opportunities by providing Statistical Process Control data to support your investigation.
  • Administer and maintain document-controlled databases to assist in Standard Operating Procedures, CAPA traceability and SPC data collection.
  • Apply expertise in ISO 9001:2015 and be familiar with upcoming ISO9001:2026 and internal Quality Management System (QMS) procedures, maintaining and generating quality documentation such as inspection reports, First Article Inspection records (FAI), APQP, PPAP, Submissions.

The essential requirements of the job include:

  • Bachelor’s degree in engineering or quality with 5+ years of Quality experience, or 15+ years of equivalent experience in Quality within a manufacturing environment in regulated industries such as medical devices or microelectronics.
  • Demonstrated success working under a formal QMS with strong discipline in documentation, change control, training records, and compliance to applicable frameworks such as CAPA expectations, ISO management-system requirements, and customer specific requirements. 
  • Ability to investigate customer complaints fast, drive containment, lead structured root-cause analysis, implement corrective actions, and verify effectiveness with objective evidence.
  • Hands-on experience with process controls (SPC/capability basics), inspection strategy, measurement system readiness (MSA/Gage R&R, Calibration Protocols), and qualification/validation activities to ensure processes consistently meet CTQ requirements.
  • Proven ability to support customer/regulatory audits, write clear technical reports, and coordinate actions across Manufacturing, Engineering, Supply Chain/Logistics, and Supplier Quality, ensuring containment is communicated plant-wide and supply continuity is protected.

It would be a plus if you also possess previous experience with:

  • SmartSolve, Minitab, Microsoft Power Apps, M365, and Power BI software
  • Knowledge of Kosher and Halal certification requirements
  • Related professional certifications such as ASQ CQE, CQA, and Six Sigma

The annual salary range for this role is $75,000 - $120,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range.

This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Check out our benefits at danaherbenefitsinfo.com.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

#LI-LCS

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].

Skills Required

  • Bachelor's degree in engineering or quality
  • 5+ years of Quality experience or 15+ years in Quality within manufacturing
  • Experience with ISO management-system requirements
  • Ability to lead structured root-cause analysis
  • Hands-on experience with process controls

Cepheid Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cepheid and has not been reviewed or approved by Cepheid.

  • Leave & Time Off Breadth PTO and paid holidays are portrayed as robust, with formal programs and mentions of generous time off and rollover in some cases. This breadth supports a positive view of time-off availability.
  • Healthcare Strength Core medical, dental, and vision coverage is highlighted repeatedly and is viewed as comprehensive for regular full‑time employees. Descriptions such as “good” or “great” benefits reinforce the strength of the health coverage.
  • Retirement Support A 401(k) plan with company matching is consistently included as part of the package. The presence of matching contributions strengthens perceived retirement readiness.

Cepheid Insights

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The Company
HQ: Sunnyvale, CA
4,883 Employees
Year Founded: 1996

What We Do

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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