Milford, MA US
- Manage and document thorough and accurate complaint records in the TrackWise system while ensuring they are processed in a uniform and timely manner. Specifically execute intake and analysis activities and open investigations when requested.
- Ensure complaint records and applicable complaint handling documents are compliant with Good Documentation Practices (GDP).
- Assess regulatory reportability of complaints e.g. MDR to FDA, and immediately escalate to management any complaints determined to meet criteria
- Work with the Field Service Organization and various manufacturing facilities to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements both domestic and international
- Collect, review, track, trend, analyze, and report complaint data generated from the complaint handling system to create metrics and reports
- Demonstrable experience in using electonic quality system tools and/or databases
- Experience in working in a regulated environment, preferably to ISO 9001 or ISO 13485
- Self-starting demonstrating initiative
- Effective communication and influencing skills.
- Good organisation skills - tracking and trending actions
- Preferable - graduate education in science subject.
- Desired - Experience with Complaint Handling in the biotechnology, medical device or pharmaceutical industry
At HW Staffing Solutions we recognize the value of our employee associates as equally as our clients. We are passionate about people and improving the lives of every associate, we do this by connecting you with great companies and great opportunities. We celebrate our awesome diversity, believe that everyone has a unique talent, and appreciate the passion and perspectives that each of us bring to the table. Discover a new way to work together with a company that is focused on offering the best opportunities, benefits and career advancement in Accounting & Finance, Office & Administrative, Light Industrial, Professional & Technical, Call Center, Food Processing and Hospitality. HW Staffing Solutions is an Equal Employment Opportunity company.
Meet Your Recruiter
Sr. Staffing Specialist
My name is Josie and I am a Sr. Staffing Specialist out of our Sutton branch. I have been with HW Staffing for 6 years totaling a total of 10 years within the Staffing Industries.