Danaher Corporation Quality Assurance Engineer in Bothell, Washington
Job Title: Quality Assurance Engineer
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).
Cepheid, Bothell, WA. is seeking a Quality Assurance Engineer responsible for ensuring product quality of enzyme, chemical and oligonucleotide reagent products and strengthening compliance to FDA’s Quality System Regulation and ISO 13485. Responsible for supporting the Operations and Development functions with facility and equipment qualification and product development and process improvements.
ESSENTIAL JOB RESPONSIBILITIES:
Support qualification and validation activities for equipment, facilities, production process and test method validation. This includes review of protocols, protocol execution, test results, deviation investigation and resolution, and final reports.
Independently plan, coordinate and report on product quality programs which provide a basis for sound technical decisions using techniques in experiment design and data analysis.
Represent QA by collaborating on product development teams focusing on design controls, process transfer, validation, monitoring and risk management.
Prepare complex data analysis for quality reports.
Resolve issues of experimental design, data discrepancies in both intra and interdepartmental experiments.
Support production related activities that include evaluation and complex problem solving.
Drive activities supporting Quality System processes to ensure compliance to the Cepheid Quality Management System.
Review change controls, deviations, CAPAs and other documents and records for accuracy, completeness, and compliance.
Identify compliance gaps, write, or revise procedures, and implement processes to improve efficiency while ensuring compliance.
May perform audits and training.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience:
BS degree in engineering or a chemistry or life science discipline and at least 2+ years of relevant work experience or a Master’s degree in field with 0-2 years relevant experience.
Experience in the application of production and process controls including process validation, process control plans and statistical process control.
Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
Knowledge and skills:
Works independently, requiring minimal guidance to meet objectives and timelines.
Solves complex problems, works on significant issues, and exercises judgments based on analysis of multiple sources of information to obtain results.
Uses best practices and knowledge to drive improvement.
Effective leadership skills and ability to develop strong partnerships and act as resource to the team. Lead projects with manageable risks.
Highly developed communication skills and ability to work effectively in diverse matrix environment.
Exceptionally strong skills in organization, accuracy, attention to detail and interpreting analytical data.
Preferred experience, knowledge and skills:
Certified Quality Engineer
Medical device manufacturing or quality experience.
Chemistry, biochemistry or molecular diagnostics.
Electronic document management, quality management, training management and/or equipment management systems.
Ability to work in an office environment.
Ability to be in laboratory environments.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
Operating Company: Cepheid