Job Title: Product Surveillance Specialist

Job Description

We are seeking a Product Surveillance Specialist to provide clinical and safety assessment of post-marketing events. This role is crucial in ensuring compliance with global regulations. The position involves minimal supervision and requires significant interaction with customers, healthcare professionals, global government agencies, and employees at all levels of the organization. Responsibilities include fielding inquiries received via phone, electronic, or verbal correspondence, documenting complaints according to applicable SOPs, providing technical support, and remote troubleshooting guidance. You will also review associated records, perform follow-ups with customers to collect information on treatments and product performance, and complete complaint records in a timely manner.

Responsibilities

• Provide clinical and safety assessment of post-marketing events.
• Maintain compliance with global regulations.
• Field inquiries received by phone, electronic, or verbal correspondence.
• Document complaints according to applicable SOPs.
• Provide technical support and remote troubleshooting guidance.
• Review associated records and perform follow-ups with customers.
• Collect information on treatments, product performance, and functionality.
• Complete complaint records in a timely manner.
• Review documentation of device fixes and perform quality reviews.
• Work with SAP for documentation purposes.

Essential Skills

• Experience in quality assurance.
• Knowledge of FDA, GMP, GLP regulations.
• Proficiency in technical writing.
• Strong computer skills (Excel, Word, Office proficiency).
• AS or BS Degree in Sciences or equivalent experience.

Additional Skills & Qualifications

• HS Diploma with 3 years experience in quality assurance.
• Customer service experience is a plus.
• Experience in regulated industries is helpful but not required.
• Strong problem-solving skills.

Work Environment

The position operates on a 1st shift schedule: 7am-3:30pm Monday through Friday, with an additional hour per day. There may be occasional requirements to work 4 hours on Saturdays, typically on a voluntary basis, but you must be comfortable with working Saturdays as needed. The company culture is family-oriented and team-focused, with a supportive environment where team members support each other. The company is dynamic and frequently undergoes changes, so the ideal candidate must be adaptable to constant and sudden changes in the role or company. Initially, there is no remote work, but employees can work from home up to 2 days a week after the initial period.

Pay and Benefits

The pay range for this position is $20.00 - $20.00

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 will be accepting applications until Dec 25, 2024.

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 for other accommodation options.

Salary : $20