Job Information
ManpowerGroup Manager, Medical Device , Complaint Handling in South San Francisco, California
Senior Manager, Medical Device Technology, Complaint Handling
Our client in South San Francisco is looking for hardworking, motivated talent to join their team. Don’t wait… apply today!
What's in it for you?
Pay range $85 - $92/hr/W2
100 %Onsite, Contract Full-Time Position
Location: South San Francisco, CA
Job Description
In this role, you will lead Complaint Investigation process and execution for product design and process related complaints for our Post-Market Medical Device Invitro Diagnostic (IVD) Products within our Design Engineering team.
Ensure that all applicable Medical Device Regulations for Complaint Handling are incorporated within local SOPs and work instructions and followed.
Developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines.
Maintain a compliant process for Complaint Files aligned with 21 CFR Part 820.198
Maintain a complaint process for Post marketing Safety Reporting (PMSR)
Specialize in leading complex cross-functional investigations teams, signaling/trending within and across complaint data
Ensure appropriate and timely flow of complaint investigation review and approval
Lead complaint monitoring and trending activities, such as data analysis, internal/external audits, CAPA related activities, post market surveillance
Work with software partners to enhance existing complaint handling systems. Participate in software verification and validation when required * *
Qualifications-Must-Have
Bachelor’s Degree and 8+ years of experience in complaint handling.
Experience working with and knowledge of 21 CFR 820.198, and 21 CFR Part 803.
Demonstrated experience with leading teams responsible for post market complaint investigations for medical devices
Experience in Regulatory Agency/Health Authority interactions
Experience in working with Combination Products and Medical Devices
Excellent understanding of local regulations around good manufacturing practices
Experience in relevant guidelines, operations and/or quality.
What's in it for you
Competitive hourly pay paid weekly!
Medical, Dental, Vision and 401K benefits
Access to free up-skilling tools and resources
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.