Quality Assurance Engineer

SHL Medical US MFG LLC; North Charleston (SC); On-site; USD 70,000 - 105,000; Full time

Benefits offered by this job

Competitive compensation package

Modern facilities and state-of-the-art

Development opportunities in global组织

Job summary

SHL Medical US MFG LLC is seeking a Quality Assurance Engineer to oversee molding production processes, launches, scale-up, manufacturing, and post-market surveillance. You will ensure SHL high quality standards and regulatory compliance across sites by collaborating with regional and global teams.

The role emphasizes change control, validation, CAPA, and continuous improvement, with a focus on product quality and documentation, using statistics and robust problem solving.

Qualifications

• Knowledge of GMP, QSR, and ISO 13485 preferred.
• Clear and logical thinking with strong organization and communication skills.
• Risk-based thinking and ability to prioritize in a cross-functional international environment.
• Experience conducting complex investigations and implementing corrective actions.

Responsibilities

• Represent Quality on product activities, supporting change control and validation.
• Support development and launch of new manufacturing equipment.
• Review product performance using statistics to identify trends and prevent issues.
• Ensure non-conformity materials are reviewed and disposed accordingly.
• Collaborate with Quality Control and manufacturing to confirm failures and support investigations.
• Establish product inspections and sampling plans aligned to customer needs.
• Assist in test methods development and transfer for reproducibility.
• Drive quality improvement projects and CAPA activities.
• Create quality engineering procedures and training materials.

Skills

Regulatory understanding

Quality assurance

Problem solving

Cross-functional collaboration

Investigations

Documentation

Education

Bachelor’s degree in Life Science/Engineering

Job description

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Quality Assurance Engineer position would support, oversighting molding production process, launch, scale up, manufacture, and post-market of SHL product to assure SHL quality high standards and compliance with applicable requirements, regulations and SOP’s. Collaborates with regional and global counterparts to ensure consistency of critical processes. Effectively works with local, regional, and global employees to ensure regulatory compliance and SHL standards maintained across different sites.

Main Responsibilities

• Team member representing Quality on product 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.
• Ensure Non-conformity Material is reviewed and disposed accordingly.
• Partner with Quality Control and manufacturing personnel to confirm failures, and support investigations.
• Stablish 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.
• 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.
• Technical writing skills for documenting progress, tracking closure of records, and creating training materials.

Skills and Qualification

• 2-5 years of experience in the medical device, pharmaceutical or related regulated industry.
• Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
• 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.
• Experience conducting complex investigations and implementing corrective actions.
• Bachelor’s degree in Life Science, Mechanical Engineering or Engineering discipline.We Offer
• 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

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit:shl-medical.com