Position : Complaints Management Specialist

Location : Sparks, MD

Duration : 6 Months contract

Total Hours/week : 40.00

1^st Shift

Client: Medical Devices Company

Job Category: Healthcare

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Work days/hours: 8am - 5pm

Job Description:

Key responsibilities will include:

• Handles activities and procedures associated with IDS product complaints.
• They will supervise the processing of customer complaints, including maintenance of complaint files, responses to customers, and Quality reports.
• They will be responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints.
• As well as supporting Market Segment Teams.
• This person must be able to lead the end to end process of customer complaints, including utilization of the database systems used to process complaints, and will be responsible for processing of customer complaints.
• Provide mentorship and education regarding customer complaint processing, MDR’s, complaint report ability, and regulatory compliance.

About you:

• Develop, implement and follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints.
• Reviews all customer complaints for validity and assures complaints are processed in compliance with policies and procedures.
• Provide mentorship, review and generates MDR reports utilizing client procedures and FDA regulations.
• Contribute to the business-wide quality strategy and quality objectives
• Maintain systems to supervise and facilitate the timely investigations and close out of open complaints.
• Ensure complaints are investigated and completed in a timely manner.
• Supervise and communicate significant complaint trends, adverse events and other pertinent reports
• Provides and analyzes organizational quality metrics as required to assess the efficiency of quality system improvements.
• Provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team.
• Interact with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns on an as needed basis.
• Ensure the customer complaint investigation, procedures, and activities follow applicable FDA and ISO requirements for complaint handling and adverse event reporting. .
• Exhibit flexibility and resourcefulness by leading assignments in accordance with project priorities and by altering course of action when and where vital
• Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information.
• Represents IDS on cross-business teams related to Quality Systems.
• Partners with other quality professionals to address recurring issues identified throughout the organization.
• Provides Education: Provides on-going education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements and initial and ongoing assessment.

Education and competences required:

Skills:

• Strong analytical, deductive reasoning and listening skills
• High level of problem identification, analysis, and formulation of conceptual / technical and business solutions
• Ability to influence without authority and deal optimally with ambiguity
• Effectively communicate precisely and accurately to all levels of the organization
• Strong product knowledge of clinical application usage and/or manufacturing process
• Strong business, technical and digital literacy
• Strong project management skills

Basic Requirements:

• Basic understanding of regulatory standards.
• Experience in health care setting where client or similar products are used, e.g. clinical labs, hospitals, ICU’s, health care delivery settings.
• Minimum of one (1) years’ experience in health care setting where client or similar products are used, e.g. clinical labs, hospitals, ICU’s, health care delivery settings.

Education:

• Minimum of BS Degree in Medical Technology, Biomedical Engineering or related healthcare / Engineering subject area.