A Post Market Surveillance Consultant is needed for a leader in electronics, healthcare, and lighting. This position is remote. This position will perform initial intake and assessment of customer complaints, initiate CAPAs, analyze complaint data, other additional data as needed. Provide feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations.
location: Remote, Remote
job type: Contract
salary: $20.00 - 29.75 per hour
work hours: 8am to 5pm
- Evaluates, investigates, and resolves complaints through various forms of communication (i.e. email, phones)
- Completes initial assessment of reportability and escalates to Potential Safety team, when necessary
- Analyzes complaint data, gathers additional data as needed, and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolves complaints
- Reviews complaint criticality and initiates necessary containment actions, escalating to the manager to determine action.
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues
- Communicating with sales representatives, physicians, lab personnel, etc. to obtain the information required in order to complete the complaint record
- Following current policies and procedures to ensure compliance with all US and international regulations relating to complaint reporting
You are a part of: Our Complaint Handling team working with Quality, Engineering, Manufacturing, and Clinical departments to complete complaint intake and assessment
To succeed in this role, you should have the following skills and experience:
- BS/BA degree or Associates degree preferred, but not required
- A minimum of 2 years experience in medically regulated industry, medical device industry is preferred
- Knowledge of US and international regulations for medical device manufacturers, including MDR and Vigilance reports
- strong organization and prioritization skills with ability to manage several tasks simultaneously.
- Independent problem solver with excellent written communication skills.
- High initiative in a fast-paced environment and Prior experience with CATSWeb preferred
- Experience level: Experienced
- Minimum 2 years of experience
- Education: Bachelors
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.