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SHL Medical · 2 days ago

QA Engineer

North Charleston, SC

Full-time

Onsite

Entry, Mid Level

2+ years exp

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. The Quality Engineer position supports process transfer, launch, scale-up, and manufacturing to ensure compliance with quality standards and regulations. The role involves collaboration with global teams to maintain regulatory compliance and drive quality improvement initiatives.

ManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Team member representing Quality on product transfer activities, providing quality insight on change control, validation of equipment and processes, and during product life cycle

Support the development and launch of new equipment for manufacturing processes

Review product performance using statistics tools to identify trends focusing on customer keeping a risk based thinking to prevent quality issues

Support investigation of observed nonconformities during manufacturing process

Support Non-conformity Material Review Board

Establish product inspections processes to assure sampling plans and procedures are align to customer’s needs

Support test methods development and transfer activities, to ensure those are reproducible by receiving unit

Participates in risk management activities including review failure mode effects analysis (FMEA), hazard analysis, fault tree analysis (FTA) and/or risk or statistical analysis

Promotes the use of statistics and a customer focus approach on product quality and control decisions

Review validation protocols and reports to ensure compliance to validation governance documents and GDP requirements

Drive Quality Improvement projects and CAPA activities to ensure prevent recurrence of observed or predicted issues and maintain a continuous improvement mentality

Supports creation of quality engineering procedures, systems and tools and applies them in a dynamic way to development and production projects

Collaborate on the review and approval of device master records

Qualification

Quality EngineeringRegulatory ComplianceStatistical AnalysisSix SigmaISO 13485Risk ManagementSAPISO 11608ISO 14971Communication SkillsTeam PlayerOrganizational SkillsSelf-StarterCross-Functional CollaborationProblem Solving

Required

Bachelor's degree in Life Science, Mechanical Engineering or Engineering discipline

2 years of experience in the medical device, pharmaceutical or biotechnology industry

Clear / logical thinking with strong organization and communication skills

Risk oriented based thinking

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

Preferred

Professional certification, such as Six Sigma, Quality Engineer are an advantage

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)

ISO 11608 and 14971 experience is added advantage

Able to travel internationally (up to 10%)

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)