SENIOR QUALITY ASSURANCE SPECIALIST
Quality Assurance

Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology and tissue-based 

diagnostics. Our core RNAscope® technology is the world’s first multiplex fluorescent and chromogenic in 

situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule 

sensitivity. RNAscope® is an ideal platform for developing the next generation of tissue-based companion 

diagnostics. We are committed to continued innovation to bridge the gap between basic research and clinical 

medicine to fulfill the promise of personalized medicine.

POSITION DESCRIPTION

Report to QA Manager, this highly creative and energetic individual is knowledgeable in compliance. Will work within a highly dynamic group to educate concepts, develop, establish, and train to ISO13485 and FDA Quality System Requirements.

2018 March 06

Education Experience

Minimum of a B.Sc. or B.A. degree in an accredited college.

Preferred Qualifications

  • 5 to 10 years experience in Quality Systems.
  • Understanding of IVD Medical Devices, Quality Management Systems (ISO 13485, QSR) development, implementation, compliance, as well as audits.
  • Fluent in CAPA, NCP, PCO, document control, audits, quality metrics, customer complaints, post-market surveillance/recalls, management review, design control and risk management.
  • Prior experience in process validation, supplier management, equipment control, and customer related processes are a plus.
  • Excellent computer skills, including working knowledge of common QA Document Control and QMS, ERP software and databases.
  • Excellent people, verbal and written communication skills.
  •  Ability to thrive and flourish in a fast-paced growing start-up environment.

Duties and Responsibilities

  • Assist and support ACD with compliance to the Quality Systems, monitoring the conformance to applicable processes & standards.
  • This individual will be responsible for monitoring and improving the following quality system elements: CAPA, NCP, Process Change Control, batch record review & release, internal and external audits, quality metrics, management review, recalls, customer complaints, risk management, supplier control and customer related processes.
  • Work closely with QA Manager, Document Control, Research, Development, Manufacturing, Operations, Technical Support and commercial teams to identify and support the Quality System compliance and customer needs. Will take initiative and be willing to learn new technologies quickly and adapt to shifting priorities.

Occasional Duties and Responsibilities

Other quality related duties as required by QA manager

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Contact Us

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Advanced Cell Diagnostics

Our new headquarters office starting May 2016:

7707 Gateway Blvd.  
Newark, CA 94560
Toll Free: 1 (877) 576-3636
Phone: (510) 576-8800
Fax: (510) 576-8798

 

Advanced Cell Diagnostics , S.r.l.

Via Calabria15
20090 Segrate (Milano) - Italy

Phone: +39.02.95360323
Fax: +39.02.95360992
For European orders: order_europe@acdbio.com

Advanced Cell Diagnostics China

Building 15, No. 26 Xihuan South Road
Beijing Economic-Technological Development Area
Beijing, China, Zip code: 100176

400-966-1796
info_china@acdbio.com
For general information: Leon Li lli@acdbio.com
Web: www.acdbio.com.cn

For general information: info@acdbio.com
For place an order: order@acdbio.com
For product support: support@acdbio.com
For career opportunities: hr@acdbio.com