Product Surveillance Associate V at Maxonic, Inc.

Job description

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Product Surveillance Associate V. Job Description: Job Title: Product Surveillance Associate V Job Type: Contract Job Location: Sturtevant , WI Work Schedule: Remote Pay Rate: $29, Based on experience Description: • The Product Surveillance Associate V performs day-to-day tasks and provides technical data assessment of post-market events and can support the Quality Department with Quality System activities including Change Control and NCR/CAPA. This position plays an integral role in maintaining compliance with global regulations. The Product Surveillance Associate V works with minimal supervision and requires a high degree of interaction with customers, health care professionals, global government agencies, and Global employees at all levels within the organization. Work Environment: • Onsite Required - Start time between 7am and 9am CST • Overtime limited - Standard work week Monday through Friday • Must be able to pass vision testing requirements at 20/20 near acuity vision (with or without corrective eyewear). Key Responsibilities: • Independently field inquiries received by phone, electronic or verbal correspondence and determine if it qualifies as a complaint; document reported issues according to applicable SOP(s). • Provide technical support and remote troubleshooting guidance as needed. • Independently review associated records, and contact users and customers to collect information on the treatment, product performance, functionality, etc. • Conduct periodic follow-up to close complaints in a timely manner. • Manage customer relationship and expectations during the course of the complaint investigation. • Independently complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure. • Develop solutions to a variety of moderate problems. • Conduct statistical analysis of complaint trends. • Support training program by training users on the complaint process and tools used to assess and investigate complaints. Process Improvement Initiatives: • Supports and may identify operational changes to improve efficiencies in all aspects of complaint handling. • Support and sometimes lead investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting. • Update internal operating procedures and specifications through the Document Change process. Compliance Initiatives: • Support and participate in internal quality system audits. Support external quality system audits. • Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required. • Support submitting MDRs and Vigilance Reports according to regulatory timelines. Education (required): • High School Diploma with 4 years of experience OR Associate's Degree with 2 years of experience OR Bachelor's Degree Work Experience: • Medical or Surgical Office Experience (preferred) • Customer Service Experience (preferred) Knowledge, Skills, Abilities: • Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. • Basic medical and/or scientific terminology. • Highly organized with attention to detail. • Strong ability to prioritize and manage multiple records/reports simultaneously. • Professional phone etiquette with the ability to appropriately handle sensitive information. • Effective communication skills including written and verbal. • Ability to work with company staff and communicate effectively throughout the organization. • Proficient in Microsoft Office Suite. About Maxonic: Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients. Interested in Applying? Please apply with your most current resume. Feel free to contact Waseem Sheikh (waseem.s@maxonic.com/ (408) 400-2322) for more details.

Requirements

Must-haves

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Product Surveillance Associate V.
Job Title: Product Surveillance Associate V
Job Type: Contract
Job Location: Sturtevant , WI
Work Schedule: Remote
Pay Rate: $29, Based on experience
Onsite Required - Start time between 7am and 9am CST
Overtime limited - Standard work week Monday through Friday
Must be able to pass vision testing requirements at 20/20 near acuity vision (with or without corrective eyewear).
Independently field inquiries received by phone, electronic or verbal correspondence and determine if it qualifies as a complaint; document reported issues according to applicable SOP(s).
Provide technical support and remote troubleshooting guidance as needed.
Independently review associated records, and contact users and customers to collect information on the treatment, product performance, functionality, etc.
Conduct periodic follow-up to close complaints in a timely manner.
Manage customer relationship and expectations during the course of the complaint investigation.
Develop solutions to a variety of moderate problems.
Conduct statistical analysis of complaint trends.
Support training program by training users on the complaint process and tools used to assess and investigate complaints.
Supports and may identify operational changes to improve efficiencies in all aspects of complaint handling.
Support and sometimes lead investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Update internal operating procedures and specifications through the Document Change process.
Support and participate in internal quality system audits. Support external quality system audits.
Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.

Nice-to-haves

Medical or Surgical Office Experience (preferred)
Customer Service Experience (preferred)

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