Global Complaint Resolution Manager at Semtech

Lincoln, Nebraska, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor's Degree
5 years of experience in customer service or complaint handling within the medical device or similarly regulated industry
Compliance with ISO 13485, FDA QSR, and EU MDR
Strong coordination, organizational, and project management skills
Familiarity with CRM systems such as Salesforce, and with ERP and eQMS platforms

Responsibilities

Serve as process owner for the global complaint handling system
Functionally lead and mentor a team of complaint specialists
Oversee complaint intake, documentation, and classification
Escalate potentially reportable events to Regulatory Affairs
Manage operational tasks for FSCA and product recalls
Focus on resolution of high-risk and high-complexity complaints
Support QA in monitoring and identifying complaint trends
Work closely with Service, QA, Regulatory Affairs, and Clinical Application Specialists to assess failure modes and track high-risk complaints and associated actions
Conduct error and problem analysis in collaboration with development teams

Skills

ISO 13485

FDA QSR

EU MDR

Salesforce

ERP

eQMS

Complaint Handling

Post-Market Surveillance

Project Management

Team Leadership

Regulatory Compliance

Field Safety Corrective Actions

Product Recalls

Semtech

High-performance semiconductors and IoT solutions

About Semtech

Semtech Corporation focuses on high-performance semiconductors, IoT systems, and cloud connectivity services. Its products include the XR60 5G Router Solution for reliable networking and LoRa technology for efficient IoT applications that support decarbonization. The BlueRiver platform enables the transmission of high-quality video over Ethernet, catering to the audiovisual industry. Semtech aims to provide advanced solutions that enhance connectivity and sustainability across various sectors.

Camarillo, CaliforniaHeadquarters

1960Year Founded

$557MTotal Funding

IPOCompany Stage

Automotive & Transportation, Hardware, Energy, Enterprise SoftwareIndustries

1,001-5,000Employees

Risks

Increased competition from Cisco and Huawei in the IoT market.

Semiconductor industry talent shortage may impact Semtech's innovation capabilities.

Rising raw material costs could squeeze Semtech's profit margins.

Differentiation

Semtech's LoRa technology aids global decarbonization through efficient IoT applications.

The BlueRiver platform enables zero-latency Ultra HD 4K HDR video over Ethernet.

Semtech's XR60 5G Router Solution offers robust 5G and Wi-Fi 6 performance.

Upsides

Growing demand for IoT solutions in elder care boosts Semtech's healthcare market potential.

Financial institutions' investments indicate strong market confidence in Semtech's growth.

Partnership with Nvidia enhances Semtech's position in high-performance computing.

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