Spectraforce is a leading global services firm that provides a portfolio of consulting, staffing and outsourcing services and solutions to a broad range of clients and industries worldwide. We are headquartered in Raleigh, NC, USA and have offshore global delivery centers in Pune, Chandigarh, Banglore and Hyderabad, India.

• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / 14971
• One(1) or more years of experience with medical terminology, clinical or laboratory knowledge, and familiarity with client`s products.
• Two (2) year or more experience in the complaint handling, Medical Device industry, Customer relations, complaint trending, MDR submissions, FDA regulations, GMP.

Skills:

• Strong analytical, deductive reasoning and listening skills
• Must be able to communicate precisely and accurately to all levels of the organization
• Ability to speak multiple languages preferred including Spanish, Portuguese, and French.
• Strong interpersonal skills with the ability to effectively lead a multi-functional audit team
• Strong project management skills

Education:

• BS Degree in Science or Engineering or Business, or applicable work experience

Complexity of Duties:

• Duties are very complex in nature and pertain to the overall in
• Under the direction of the Manager, Customer Management Center, manages activities and procedures associated with complaints concerning client`s products.
• Accountable for setting own work direction and completing work tasks.
• Supervise the processing of customer complaints including maintenance of complaint files, responses to customers and Quality reports.
• Responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints. As well as supporting Market Segment Teams.
• Able to manage the end to end process of customer complaints including utilization of the database systems used to process complaints.

Responsibilities:

• Contribute to the business-wide quality strategy and quality objectives
• Maintain systems to monitor and facilitate the timely investigations and close out of complaints. Ensure systems workflow precludes lengthy unanswered complaints.
• Manage the process of the complaint handling system

Thanks & Regards
Monika Kanwar

Client Delivery Executive

Spectraforce Technologies Inc.
Phone No# 919-887-6786 EXT-4065
Fax No# 919-573-9398
Email: [email protected]
Visit us: http://www.spectraforce.com