"Alerted.org

Job Title: Product Surveillance Analyst - Lab

Job Description

As a Product Surveillance Analyst, you will perform evaluations on various types of returned medical devices associated with reported complaints. Your role involves using procedures, judgment, and experience to determine appropriate testing, conducting well-documented and accurate root cause evaluations, reviewing Device History Records, coordinating product testing and analysis with internal departments and external consultants, and preparing technical reports of evaluations. You will analyze and submit complaints and investigate returned products from the field, requiring comfort with handling biohazardous materials.

Responsibilities

+ Receive complaints from customers and field personnel, ask relevant questions, and submit evaluations on findings.

+ Analyze and investigate returned products from the field, ensuring compliance with regulatory requirements.

+ Support electrophysiology products by auditing files for completeness, ensuring proper documentation practices, and electronically closing files in the complaint system.

+ Collate and file complaint folders in designated places and prepare documents for archival.

+ Support Company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

+ Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

+ Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Essential Skills

+ Bachelor's Degree in a science-related field (biology, biochemistry, neuroscience, etc.).

+ 0-2 years of experience within a lab or medical space.

+ Technical writing experience.

+ Proven ability to communicate effectively and efficiently.

+ Strong customer service skills.

+ Biology and postmarket surveillance knowledge.

+ Proficiency in Excel and Microsoft Word.

Additional Skills & Qualifications

+ Knowledge of heart anatomy.

+ 3+ months of lab experience and/or anatomy/physiology experience.

+ Experience in lab work, teaching assistant roles, or research during college.

Work Environment

You will work in a team environment but also perform individualized tasks. The role involves 60% desk work and 40% lab work. You will be part of a specific group of 9 people within the larger electrophysiology team, which consists of about 85 people in Minnesota. The postmarket surveillance group resides within the Quality department. Training for this role will take approximately 2-3 months, depending on the individual's learning pace.

Pay and Benefits

The pay range for this position is $19.00 - $21.00/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 Plymouth,MN.

Application Deadline

This position is anticipated to close on Jun 17, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.