(Sr.) Quality Engineer Assembly

SHL Medical • Charleston, SC

2d

About The Position

The Quality Engineer Assembly is responsible for leading and improving manufacturing process quality within a regulated medical device environment. This role ensures that production processes are capable, stable, and compliant with internal procedures, global regulatory standards, and mass production need. You will collaborate closely with Operational Engineering, Process Engineering, and Quality teams to drive receiving tech transfer equipment, execute validation activities, and ensure product and process quality performance meet business, customer, and regulatory expectations.

Requirements

• Bachelors or Masters degree in Engineering (Mechanical, Industrial, Manufacturing, or related).
• Minimum 3 years of experience in Process or Quality Engineering within a medical device or regulated manufacturing environment preferred.
• 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.

Nice To Haves

• Six Sigma Green Belt or higher certification preferred.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level