Job Title: Quality Assurance Specialist I

Job Location: India-Karnataka-Bengaluru

GCRF Job Family: Quality and Regulatory

About Us

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).

JOB DESCRIPTION

POSITION SUMMARY:

This position supports Operations activities such as non-conformance investigations and dispositions, CAPA requests, and is responsible for the maintenance of Quality System documentation as related to batch record compliance and ensuring accuracy and traceability of data and in accordance with the requirements of India MDR, IVDD/IVDR/ISO 13485.

This position is part of the Quality Organization and will be in Bengaluru, India. Our mission is to ensure that performed Quality Systems activities are done by focusing on the quality of the product, the internal and external customer needs, and according to the Quality System, IVDR and ISO regulations.

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 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.

Assist to improve standard operating procedures 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.

NOTE: 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) 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)

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.

PREFERRED REQUIREMENTS:

Experience in Validation Process, Non-conformance process, MRB, and CAPA process.

Experience representing 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 Visio and Project knowledge desirable.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 70,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $20 B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

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.

Read Full Description
Confirmed 20 hours ago. Posted 30+ days ago.

Discover Similar Jobs

Suggested Articles