QUALITY CONTROL TECHNICIAN

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.

SKILLS AND QUALIFICATION

• Bachelor’s Degree in Science or equivalent experience will be considered.
• 2-4 years’ experience in testing equipment set-up, maintenance, and troubleshooting.
• Minimum 2 years of experience in quality control, using inspection tools.
• Advance knowledge of ISO 13485, GMP, FDA Compliance, CAPA, and Risk Management
• Experience with quality investigations preferred
• Knowledge and experience working with sampling plans
• Knowledge of Good Documentation Practices (GDP).
• Knowledge of Good Manufacturing Practices (cGMP).
• Proficient in the use of Microsoft Products (Word, Teams, Excel, PowerPoint, PLM Systems, and SAP).

• Performs review of QC-generated testing and inspection data.
• Performs technical training.
• Assists other departments with the development of validation plans impacting QC.
• Performs quality activities to support the Product manufacturing process.
• Inspects incoming materials, in-process materials and finished products per applicable procedures, protocols and/or batch record requirements.
• Performs device testing and visual inspections in support of product realization, stability studies, and validations.
• Notifies management of nonconforming material or test failures in a timely manner.
• Segregates nonconforming materials per applicable procedures.
• Performs product identification and traceability activities as required (e.g. Quarantine)..
• Initiates and assists in the Nonconformance reports investigations, and implementation of corrective actions.
• Initiates and assists with document updates (QOP, QWI, and TS).
• Complies with all quality, safety, and work rules and regulations
• Must be flexible to work a variety of schedules to meet business needs.
• Perform other related duties as assigned.