- 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
