Job Title: Product Surveillance SpecialistJob Description As a Product Surveillance Specialist, you will provide clinical and safety assessments of post-marketing events. This position plays an integral role in maintaining compliance with global regulations. You will work with minimal supervision and engage in high levels of interaction with customers, healthcare professionals, global government agencies, and employees at all organizational levels. You will field inquiries received by phone, email, or verbal correspondence and document them as complaints according to applicable SOPs. The role also involves providing technical support and remote troubleshooting guidance, reviewing associated records, and performing follow-ups with customers to collect information on treatments, product performance, and functionality to complete complaint records in a timely manner. Responsibilities + Field inquiries from customers and healthcare professionals, documenting them as complaints according to SOPs. + Provide clinical and safety assessments of post-marketing events. + Offer technical support and remote troubleshooting guidance. + Review associated records and perform follow-ups with customers to gather information on treatments and product performance. + Document interactions and resolutions in the system, including reviewing what was done to devices to fix them and performing quality reviews. + Engage in SAP work as needed. + Communicate frequently via email, especially with international customers. Essential Skills + Quality assurance experience. + Experience with FDA, GMP, GLP, and medical devices. + Strong technical writing skills. + Proficiency in Microsoft Office Suite (Excel, Word). + Excellent problem-solving skills. Additional Skills & Qualifications + AS or BS Degree in Sciences or a High School Diploma with 3+ years of experience in quality assurance. + Customer service experience is a plus. + Experience in a regulated industry is helpful but not required. Work Environment The position is a 1st shift role, with hours from 7am-3:30pm, Monday to Friday, and an additional hour per day. You may be asked to work 4 hours each Saturday, though this is typically voluntary but mandatory if requested. The company culture is family-oriented and supportive, with a team that supports one another. The company regularly undergoes changes, so the ideal candidate must be adaptable to constant and sudden changes. Initially, there is no remote work, but once hired, employees can work from home up to 2 days a week. Pay and Benefits The pay range for this position is $20.00 - $22.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Sturtevant,WI. Application Deadline This position is anticipated to close on Feb 14, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.