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SHL Medical · 1 month ago

Senior Quality Engineer Molding

North Charleston, SC

Full-time

Onsite

Senior Level

5+ years exp

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. The Senior Quality Engineer – Molding is responsible for ensuring the quality and robustness of injection molding processes and supporting processes used in the manufacture of medical devices and components, while collaborating with various engineering and quality teams to ensure compliance with regulatory standards.

ManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Lead and oversee all quality-related activities for injection molding processes, from techtransfer receiving to mass production

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

Maintain Process-FMEA (PFMEA) and control plans to proactively identify and mitigate risks

Drive root cause analysis and CAPA implementation for quality issues, ensuring effective containment, correction, and prevention

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

Provide mentorship and technical guidance to quality engineers, technicians, and cross-functional team members

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

Qualification

Injection moldingProcess validationISO 13485Statistical analysisQuality toolsGreen Belt certificationLeadership skillsCommunication skills

Required

Bachelor's degree or above in Mechanical, Manufacturing, Polymer, or related Engineering field

5+ 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 and leadership 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)