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Complaint Specialist (QA)

Sunrise Systems Inc Pleasanton, CA
  • Expired: 8 days ago. Applications are no longer accepted.

Sunrise System Inc. is currently looking for QA Complaint Specialist Associate in Pleasanton, CA with one of our top client.

Job Title: QA Complaint Specialist Associate

Job Id: 20-02535

Location: Pleasanton, CA 94588

Duration: 12 months

Position Type: Hourly contract Position (W2 only)


· The primary responsibility of this position is the investigation, analysis, resolution, trending of all complaints.

· Specific responsibilities include; while maintaining the complaint files.

· Essential Duties and Responsibilities include the following (other duties may be assigned.):

· Being point of contact with customers and patients.

· Providing excellent customer service and guiding customers and patients through complaint reporting process.

· Day-to-day review of service calls to identify and categorize complaints

· Establishes and maintains complete complaint files for all customer complaints

· Responsible for investigating complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis

· Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action

· Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints

· Will communicate directly with customer to resolve complaints

· Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving complaints

· Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations


· Bachelor's degree in science or other technical discipline or a minimum of 2 years’ relevant work experience preferred

· Minimum of 1 year of experience in FDA regulated medical device manufacturing environment(s) preferred

· Knowledge of QSR, ISO13485, and ISO14971

· Problem solver.

· Self-directed.

· Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.

Additional Requirements

· Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.


Monik. M

Direct: 732-272-0278 | Email:


Michael Peng

Direct: (732) 272 0265 |

Sunrise Systems Inc

Why Work Here?

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.


Pleasanton, CA 94588
Pleasanton, CA