QA Engineer -Operations

Deerfield Beach, United States of America

Full-time (100%) Associate

Quality Engineer
- Operations

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.

Reporting to the Quality Assurance Manager, this role provides Quality Assurance oversight of GMP operations to ensure that products are consistently manufactured in a state of control, fit for their intended use, and compliant with cGMP requirements and applicable regulatory filings.

The QA Engineer supports quality operations within the manufacturing areas and works collaboratively with Process Development (MS/AS), Operations, and Quality Control. Responsibilities include oversight of manufacturing activities to ensure compliance with GMP requirements related to the manufacturing environment, product testing, equipment readiness, plant hygiene, process validation, personnel training, and material and process flow. In addition, this role is responsible for the application of Quality Risk Management principles to identify, assess, control, and mitigate risks to product quality and patient safety.

The QA Engineer lead and/or support Investigation related to deviations, nonconformances, and atypical events, ensuring robust root cause analysis, appropriate CAPA, and measurable effectiveness.

• Provide Quality Assurance oversight of GMP manufacturing operations to ensure ongoing compliance with cGMP, regulatory filings, internal procedures, and applicable standards (e.g. FDA QSR, ISO 13485).
• Support day‑to‑day quality operations within manufacturing areas, including real‑time floor support and review of activities impacting product quality.
• Apply Quality Risk Management (QRM) principles in accordance with ICH Q9 / ISO 14971 to identify, assess, control, and mitigate risks to product quality and patient safety.
• Support Design Transfer activities by providing quality oversight during the transfer of products and processes from development to commercial manufacturing, including review and approval of transfer documentation, risk assessments, validation strategies, and readiness assessments.
• Participate in cross‑functional Design Transfer and Customer Project teams to ensure quality requirements, regulatory commitments, and customer expectations are effectively integrated into manufacturing operations.
• Review, approve, and support investigations related to deviations, nonconformances, and atypical events, ensuring timely root cause analysis and effective corrective and preventive actions (CAPA).
• Collaborate with Process Development (MS/AS), Operations, Quality Control, and Engineering to maintain a state of control across manufacturing processes, equipment, and systems.
• Provide quality oversight for process validation, including protocol review, execution support, data evaluation, and final reporting.
• Ensure compliance and readiness of manufacturing equipment, facilities, and utilities through support of qualification, validation, change control, and maintenance activities.
• Monitor compliance of the manufacturing environment, including plant hygiene, contamination control practices, material flow, and personnel behaviours.
• Review batch record documentation, test results, and release documentation to ensure accuracy, completeness, and compliance with regulatory and quality system requirements.
• Perform and/or support QA batch disposition decisions (release, rejection, quarantine) based on documented evidence, investigation outcomes, and risk‑based justification.
• Ensure adherence to data…