Quality Control Engineer jobs in United States
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SHL Medical · 13 hours ago

Quality Control Engineer

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. The Quality Control Engineer will be responsible for developing documentation for the QC Lab, training QC Inspectors, and managing QC equipment to ensure effective testing for production and validation activities.

ManufacturingMedical Device
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H1B Sponsor Likelynote

Responsibilities

Develop documentation (work instruction, training material, etc.) for the QC Lab
Train QC Inspectors to new test methods / equipment
Liaison and receive test method / system updates from Metrology, Testing, and transfer team
Review planned equipment for QC lab, ensure meets local SHL expectations, and will work in the QC Lab
Attend Planning meetings for New Products to understand New Measuring Methods and plans for QC Testing
Coordinate local support (calibration / preventive maintenance) for new QC Lab equipment
Point of Contact for QC Lab for any upcoming changes or needs
Identify problem statements and build relationship with external SHL support teams for issues related to internal systems (SAP, EiQMI, and MES)
Manage all QC equipment and tool/fixtures to ensure QC Lab testing for production and validation activities
Performs other related duties as assigned

Qualification

Medical device experienceRegulatory compliance knowledgeSAP proficiencyWork instruction writingCommunication skillsTeam playerProblem-solving skills

Required

Bachelor's degree in Engineering or Life Science discipline
2+ years of experience in the medical device, pharmaceutical or biotechnology industry
Clear / logical thinking with strong organization and communication skills
Ability to prioritize and to thrive in a cross-functional, inter-company and international environment
Team player and self-starter, able to perform with low supervision
A solution-oriented growth mindset coupled with decision-making skills
Experience writing work instructions, training material, and validation documentation

Preferred

Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred
SAP (Enterprise Resource Planning quality module will be an advantage)

Benefits

Competitive compensation package
Modern working environment with state-of-the-art facilities and technologies
Challenging assignments in a fast growing and innovative industry
Position in a dynamic, international team of highly skilled professionals
Various opportunities for personal and professional development within a global organization

Company

SHL Medical

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SHL designer, developer, and manufacturer of advanced drug delivery devices such as autoinjectors, pen injectors, and inhaler systems.

H1B Sponsorship

SHL Medical 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 (2)

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
EQT
2022-12-09Secondary Market
2020-01-04Private Equity

Leadership Team

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Mats Persson
Vice President, Europe
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Nicholas Heaton
Global Head of Sales
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Company data provided by crunchbase