Apply on Employer Site

SHL Medical · 1 day ago

(Sr.) Quality Engineer Assembly

North Charleston, SC

Full-time

Onsite

Mid, Senior Level

3+ years exp

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. The Quality Engineer Assembly is responsible for leading and improving manufacturing process quality within a regulated medical device environment, ensuring compliance with internal procedures and global regulatory standards while collaborating with various engineering teams.

ManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Develop and maintain process documentation including FMEA and control plan

Review and refine process validation (IQ/OQ/PQ) activities, ensuring mass production representing validation

Drive continuous improvement initiatives focusing on upskilling production workforce, fool prove controls as process risk mitigation and systematically addressing the root cause of mass production nonconformities and deviations during process qualification & validation

Collaborate with related QE team around the world on acquiring equipment operation knowledge and ensure it is transferred to US site via suitable measures included but not limited to training material, working instruction, maintenance instruction, etc

Collaborate with cross-functional teams (Process Development, Operation Engineering, Manufacturing, QA, QC) during Tech Transfer Receiving to ensure robust process controls, representative assembly validation, and smooth transitions to mass production

Responsible for localizing the received P-FMEA to ensure local risks are captured and mitigated properly before handing the equipment to mass production

Support QA in root-cause investigations and implement effective Corrective and Preventive Actions (CAPA) to address process non-conformities related to assembly process

Support internal, customer, and regulatory audits and inspections, providing process-related evidence and documentation

Participate in risk-management activities, ensuring risk controls are verified, validated, and maintained throughout the product lifecycle

Qualification

Process ValidationFMEAQMS RequirementsStatistical AnalysisSix Sigma Green BeltCross-functional CommunicationRisk-based Decision MakingStructured Problem SolvingAttention to Detail

Required

Bachelors or Masters degree in Engineering (Mechanical, Industrial, Manufacturing, or related)

Strong knowledge of QMS requirements (ISO 13485, ISO 14971, FDA 21 CFR 820)

Hands-on experience with process validation, FMEA, SPC, and statistical analysis tools

Proven ability to perform data-driven analysis and implement measurable process improvements

Experience in risk-based decision-making and structured problem-solving

Excellent cross-functional communication skills and attention to detail

Preferred

Minimum 3 years of experience in Process or Quality Engineering within a medical device or regulated manufacturing environment preferred

Six Sigma Green Belt or higher certification preferred

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

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

Founded in 1989

Zug, Zug, CHE

5001-10000 employees

https://www.shl-medical.com/

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)