Complaint Mgmt specialist 3 jobs in United States
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Pyramid Consulting, Inc · 3 weeks ago

Complaint Mgmt specialist 3

Pyramid Consulting, Inc. is a leading Healthcare Industry company, and they are seeking a Complaint Management Specialist 3 for a contract position. The role involves conducting product complaint investigations, ensuring regulatory compliance, and collaborating with technical teams to resolve customer complaints.

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H1B Sponsor Likelynote

Responsibilities

Conduct product complaint investigations and write failure investigation reports
Ensure accuracy for complaint file documentation and regulatory reporting decision activities
Ensure complaint files are accurate and complete and in line with good documentation practices
Demonstrate sound independent decision making in regard to medical device reporting and other functions relating to the investigation of product complaints. Asks questions of team leaders / management as needed
Provide or facilitate expertise/troubleshooting for customers as appropriate
Collaborate with technical team or manager to assess the severity of complaints and understand the typical use to provide input to the technical investigation for optimal root cause resolution as needed
In concert with the department supervisor and/or manager and escalation teams, strategize to direct the efforts to ensure customer satisfaction
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Ensure timely follow-up with customers and company representatives for reported issues

Qualification

Complaint HandlingInvestigationMedical Device ExperienceRegulatory ComplianceCritical ThinkingDocumentation PracticesTechnical SkillsQuality Audits SupportElectronics KnowledgeWriting SkillsProblem SolvingAdaptability

Required

Skills-Board Circuit/ PCB/ medical device or electrical equipment/'INFUSION PUMP' OR DISPOSABLE OR 'DISPOSABLE TUBING
Complaint Handling
Investigation
Critical thinking skills
Ability to solve problems and to meet multiple deadlines within a fast-paced environment
Excellent writing skills, knowledgeable of good documentation practices
Ability to work on multiple projects with various disciplines
Ability to adapt quickly in an ever-changing environment
Ability to work in a complaint investigation laboratory environment containing hazardous materials
Able to utilize computers for development of reports and summary of project experience including word processing and spreadsheet computer applications such as Microsoft Word, PowerPoint and Excel
Ability to read, analyze, and interpret common scientific and technical journals, and legal documents
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Ability to effectively present information to management, ancillary departments, and/or customers
Ability to apply clinical and technical skills to regulatory functions
Provide support for internal quality audits of complaint files / MDR documentation, as well as external audits/inspections from Regulatory Bodies as requested

Preferred

Bachelor's degree in related field is desirable
3 years of medical device experience is desired, preferably in a regulatory or technical complaint investigation capacity. Knowledge of the use of infusion pumps and disposable tubing equipment is desired but not necessary
2 years of experience with medical device complaint handling / post-market surveillance / medical device regulations or experience in a similar regulated environment preferred
Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry preferred
Knowledge of electronics is preferred

Benefits

Health insurance (medical, dental, vision)
401(k) plan
Paid sick leave (depending on work location)

Company

Pyramid Consulting, Inc

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Pyramid Consulting, a global leader in workforce and technology solutions, empowers individuals and organizations to transform and thrive in the most challenging and competitive markets.

H1B Sponsorship

Pyramid Consulting, Inc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (178)
2024 (112)
2023 (95)
2022 (62)
2021 (50)
2020 (117)

Funding

Current Stage
Late Stage

Leadership Team

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Ramesh Maturu
President and Co-Founder
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Manish Kaushik
Chief Financial Officer
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Company data provided by crunchbase