Quality Systems Specialist III

Company: Cepheid
Location: Sunnyvale
Posted on: November 18, 2021

Job Description:

POSITION SUMMARY:
Responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485 (ISO). Specifically, functions including record review, product release and document control fall under this position.

Shift: Wed-Sat (8:00pm to 6:30am)

ESSENTIAL JOB RESPONSIBILITIES:
Review records and documents, for completeness and compliance with QSR and ISO requirements.
Review batch record 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 procedure and improve quality systems 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.
May lead and participate in interdepartmental initiatives for continuous improvement.
Provide guidance on general quality principles and specific procedural requirements.
Perform and complete work with a limit degree of supervision.
May provide continuous improvement to the processes and procedures.
May provide on-job training and/or qualification exam to junior specialists.
Complete the assigned tasks, as needed.

TRAINING RESPONSIBILITIES: (REQUIRED)

Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience (in years):
High School degree (or equivalent experience) with 4-6 years of related work experience OR
AA or Technical Degree with 2-4 years of related work experience.

Knowledge and Skills:

Excellent verbal and written communication skills in group or one-on-one settings.
Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
Understanding of general mathematical principles and calculations.
Ability to perform routine statistical applications.
Experience in compiling data to support metrics analyzing current process.
Understanding the general laboratory failure investigation, qualification/validation process, root cause analysis, and troubleshooting principles.
Computer skills: Microsoft Office: word, excel, access, power point, Microsoft project; Agile, SmartSolve, MES and XpertERP.

PREFERRED REQUIREMENTS:
Experience in DNA diagnostics or other medical devices
Experience in Kaizen, Daily Management (DM) and GEMBA.
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.

When you join us, you'll also be joining Danaher's global organization, where 69,000 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.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.

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. 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.

The EEO posters are available here .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

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

Keywords: Cepheid, Sunnyvale , Quality Systems Specialist III, Other , Sunnyvale, California