Job Description

Title: Complaints Customer Service

Location: San Diego, CA

Duration: 6 Months Contract

Job Description:

This is a complaints coordinator position (not customer service rep II) for medical device products

Responsibilities:

• Review and approve complaints to ensure that records meet Philips and regulatory requirements 

• Responsible for day-to-day complaint management of quality, technical and adverse event complaint records, including intake, follow up, triage and entry, in accordance with local and international regulations, guidelines, and applicable directives. 

• Receive initial complaint from any source (external and internal) and ensure all information/data is accurately captured at point of contact 

• Maintain an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives. 

• Review complaint data, assess for report ability and escalate to the safety teams for reportability assessment. 

• Performs intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per requirements and directives. 

• Triage call from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit. 

• Reviews data entry and follow-up activities for completeness and timeliness 

• Closes files according to established guidelines to meet required timelines 

• Maintains a working knowledge of company policies and procedures, departmental processes, and associated procedures and work instructions ,Philips IGT devices for IFUs, Manuals, Promotional Material; coronary and therapeutic procedures 

• Informs management of potential safety issues, emerging trends and/or concerns 

Minimum requirements:

• Bachelor's degree or equivalent years of directly related experience 

• English 

• Minimum of 2-3 year directly related experience 

• Knowledge of FDA/QSR requirement & quality systems in Pharma and/or Medical device experience required (i.e. 21 CFR Part 820, Quality System Regulations , 21 CFR Part 803, Medical Device Reporting , The Privacy Rule, HIPAA , ISO 13485) 

• Solid knowledge of word processing, spreadsheet, database and presentation applications 

• Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members.

If you are available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please send the updated resume to srini@apninc.com along with a best time and number to reach you.

Your prompt response is highly appreciated. 

Thanks and have a blessed day ahead.

Thanks and Regards,

Srinivas Mallipog

Resource Executive

APN Software Services, Inc (www.apninc.com)

39899 Balentine Drive, Suite 385, Newark, CA 94560

Phone: 510-943-4054 / Fax 510-623-5055 

Email Id: srini@apninc.com