Product Surveillance Associate

JobDiva, Inc.; Sturtevant (WI); On-site; USD 30,000 - 42,000; Full time

Job summary

JobDiva, Inc. in Sturtevant, WI is seeking a quality systems professional to perform technical data assessments of post-market events and support global regulatory compliance.

The role involves handling customer inquiries, investigating complaints, reviewing records, and coordinating with regulatory agencies to ensure adherence to ISO 13485, FDA QSR, and GMP standards. Onsite work with start times between 7am and 9am CST.

Qualifications

• High School Diploma with 4 years of experience or equivalent
• Associate's Degree with 2 years of experience or Bachelor’s Degree
• Familiarity with ISO 13485 QMS and FDA QSR basics

Responsibilities

• Field inquiries and determine if they are complaints per SOPs
• Provide technical support and remote troubleshooting
• Review records and collect information on treatment and product performance
• Conduct follow-ups to close complaints in a timely manner
• Manage customer relationships during investigations
• Complete investigations including product returns and evaluations
• Develop solutions and analyze complaint trends
• Support training on complaint process and tools
• Lead investigations related to deviations, CAPAs, scrap and report quality improvements
• Update SOPs via Document Change process
• Participate in internal and external audits
• Evaluate complaints for MDR or Vigilance reporting requirements

Skills

Communication skills

Microsoft Office

Attention to detail

Prioritization

Education

High School Diploma with 4 years experience

Associate's Degree

Bachelor's Degree

Tools

Microsoft Office Suite

Job description

Up to $26 per hour Sturtevant, WI Onsite Contract

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Job Description

Are you ready to make a significant impact by ensuring product safety and compliance on a global scale?

About the Role

The role involves performing technical data assessments of post-market events and supporting quality system activities, ensuring compliance with global regulations. This position is crucial for maintaining the integrity of the organization's quality systems and involves significant interaction with customers, healthcare professionals, and regulatory agencies.

Key Responsibilities

• Field inquiries received by phone, electronic, or verbal correspondence, determine if they qualify as complaints, and document issues according to SOPs.
• Provide technical support and remote troubleshooting guidance as needed.
• Review records independently and contact users and customers to collect information on treatment, product performance, and functionality.
• Conduct periodic follow-ups to close complaints in a timely manner.
• Manage customer relationships and expectations during complaint investigations.
• Complete investigations, including product returns and evaluations, review manufacturing records, and obtain necessary approvals for closure.
• Develop solutions to moderate problems and conduct statistical analysis of complaint trends.
• Support training programs by training users on the complaint process and tools used for assessment and investigation.
• Support and potentially lead investigations related to product deviations, non-conformances, CAPAs, scrap and rework, and analyze data for quality improvement and reporting.
• Update internal operating procedures and specifications through the Document Change process.
• Participate in internal quality system audits and support external audits.
• Evaluate complaints to determine if a Medical Device Report (MDR) or other Vigilance Report is required and support their submission according to regulatory timelines.
• High School Diploma with 4 years of experience OR Associate's Degree with 2 years of experience OR Bachelor's Degree.
• Familiarity with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Basic medical and/or scientific terminology knowledge.
• Highly organized with attention to detail.
• Strong ability to prioritize and manage multiple records/reports simultaneously.
• Professional phone etiquette with the ability to handle sensitive information appropriately.
• Effective communication skills, both written and verbal.
• Proficiency in Microsoft Office Suite.

Preferred Qualifications

• Experience in a medical or surgical office setting.

Physical Requirements

• Must be able to pass vision testing requirements at 20/20 near acuity vision (with or without corrective eyewear).
• Onsite work required with a start time between 7am and 9am CST.
• Standard work week from Monday through Friday with limited overtime.

We're proud to be an Equal Opportunity Employer and are committed to fostering an inclusive, people-first recruiting experience.