Quality Assurance Specialist-I

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

ESSENTIAL JOB RESPONSIBILITIES:

• Review records and documents, for completeness and compliance with regulatory requirements and ISO requirements.
• Review Batch Records/Device History Records (DHR) to support the release of raw materials, work in progress, and final products.
• This includes reagents, components, and instrumentation-related products.
• Collaborate with other function teams to resolve batch record discrepancies or errors as it related to Good Documentation Practice.
• Review and assist to improve standard operating procedures/ operation processes and quality system functions.
• Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Report, as needed.
• Support PDR closure, as needed.
• Support for internal and external audit for site.
• Preparing and implementing quality assurance policies and procedures
• Performing routine inspection and quality tests
• Address and discuss issues and proposed solutions with cross functional departments
• Be proactive in identifying process and knowledge gaps, and effectively manage escalations
• Identify opportunities for increasing operational efficiencies
• Display an appreciation of control, quality and risk related issues. Ensure existent controls are followed by team

• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

TRAINING RESPONSIBILITIES: (REQUIRED)

• Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience:

• Master’s degree in science (Biochemistry, Biotechnology, Pharmacy), medical or technical field and 5+ years’ Quality assurance experience.
• Experience with in Vitro Diagnostics (IVD) and Medical device is very beneficial and highly desirable

Knowledge and skills:

• Hands on Experience on IVD product testing.
• Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS.
• Must be flexible to work off-shifts and weekends as per production Schedule.
• Schedule orientated (able to consistently maintains schedules and meet timelines)

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  Strong interpersonal skills, Effective organization and Communication skills are essential.
• Good skills in English language
• Knowledge of Microsoft Word and Excel
• Strong multi-tasking and attention to details skills.
• Working knowledge of tools, methods and concepts of quality assurance
• Excellent data collection and analysis skills

PREFERRED REQUIREMENTS:

• Experience in Validation Process, Non-conformance process, MRB, and CAPA process.
• [[}} epresenting their department during Internal and External Quality system audits
• Experience in the medical device industry, knowledge of ISO 13485 and MDR, 2017
• Experience in leading continuous improvement efforts, in both quality systems and products.
• Knowledge of the process of establishing facility QMS certifications.

Cross functional experience with products and manufacturing processes to influence change at all levels within the organization

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.