Quality Manager - OEM jobs in United States
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Medline · 14 hours ago

Quality Manager - OEM

Medline is a growing worldwide organization that specializes in healthcare products. They are seeking a Quality Manager to manage quality and compliance for products and processes, ensuring regulatory compliance and customer satisfaction while overseeing departmental operations.

Consumer GoodsHealth CareHospitalityManufacturingMedical
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H1B Sponsor Likelynote

Responsibilities

Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product
Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction
Manage complaints and develop new approaches to solve problems identified during the investigation process
Identify and manage the execution of continuous improvement projects. Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint
Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components
Ensure all quality issues are resolved to customer satisfaction, in a timely manner. Resolve issues relating to product or production quality by interfacing with internal and external customers
Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments
Day-to-day operations of a group of employees
May have limited budgetary responsibility and usually contributes to budgetary impact
Interpret and execute policies for departments/projects and develops
Recommend and implement new policies or modifications to existing policies
Provide general guidelines and parameters for staff functioning
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies

Qualification

Quality ManagementRegulatory ComplianceMedical Device ExperienceData AnalysisMicrosoft ExcelProject CoordinationSupervisory ExperienceContinuous Improvement

Required

Bachelor's degree in Engineering, Science, or Technical Field
At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR)
Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions
Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines
Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table)
Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally)

Preferred

At least 2 years of supervisory/managerial experience
Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries

Benefits

Health insurance
Life and disability
401(k) contributions
Paid time off

Company

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.

H1B Sponsorship

Medline 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 (344)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)

Funding

Current Stage
Public Company
Total Funding
$0.5M
Key Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M

Leadership Team

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Steve Miller
Chief Operating Officer
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Amanda Laabs
Chief Product Officer
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Company data provided by crunchbase