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SHL Medical · 1 week ago

(Sr.) Quality Engineer Molding

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 Molding Quality Engineer is responsible for ensuring the quality and robustness of injection molding processes used in the manufacture of medical devices, including risk assessment, validation strategy review, and collaboration with cross-functional teams.

ManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Collaborate with engineering, tooling, QC, QA, and production teams to ensure sufficient controls for mass production components to meet defined quality requirements

Review and improve Process Validation (IQ/OQ/PQ) for end-to-end molding process and ensure all activities comply with regulatory, QMS requirements, and mass production needs

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

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

Ensure proper documentation and traceability in accordance with internal procedures and regulatory requirements

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, supplier, and customer audits as the molding process quality subject matter expert (SME)

Qualification

Injection molding processesProcess validationRegulatory requirementsStatistical analysisQuality toolsPolymer materialsGreen Belt certificationBlack Belt certificationCommunication skills

Required

Bachelors degree or above in Mechanical, Manufacturing, Polymer, or related Engineering field

3+ years of experience in Quality or Manufacturing Engineering, with at least 3 years focused on injection molding in a regulated industry (medical device preferred)

Deep understanding of injection molding processes, tooling design, polymer materials, and process optimization

Strong knowledge of regulatory and quality system requirements (ISO 13485, ISO 14971, FDA 21 CFR 820, GMP)

Skilled in statistical analysis and quality tools such as Minitab, SPC, DOE, and FMEA

Proven experience in process validation, metrology, and dimensional analysis

Excellent communication skills with ability to influence cross-functional teams

Preferred

Green Belt or Black Belt 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)