What are the responsibilities and job description for the Operations Quality Support position at SHL Medical?
Quality Support Specialist
Location: Charleston, South Carolina, US
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 Support position is responsible for assisting in operation related quality documentation and tasks including but not limited to open/write up NCMRs and/or ABNs with known root cause and has standard way of revolving. This position will also be responsible for reworking activities that are approved by SHL customers but are not part of daily operation of molding and/or assembly.
Main Responsibilities
For more information on SHL Medical, please visit: shl-medical.com
Location: Charleston, South Carolina, US
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 Support position is responsible for assisting in operation related quality documentation and tasks including but not limited to open/write up NCMRs and/or ABNs with known root cause and has standard way of revolving. This position will also be responsible for reworking activities that are approved by SHL customers but are not part of daily operation of molding and/or assembly.
Main Responsibilities
- Supporting incoming, in-process, and final inspections of materials and products according to established standards.
- Assist in collecting and recording quality data (e.g., defect tracking, inspection results, test results).
- Support non-conformance reporting (NCR), including logging and following up on activities.
- Lead non-conformance reporting (NCR) that required minimum Quality Organization supervision.
- Spot auditing on adhering to working instructions and SOPs, or specific topics/checks aligned with quality when appropriate
- Support the Quality Engineers in investigation and/or improvements.
- Associate degree or vocational training in engineering, manufacturing, or quality-related fields (bachelor’s degree is a plus) or equivalent experience.
- 1 year of experience in a quality, production, or lab environment preferred.
- Basic knowledge of quality standards (e.g., ISO 9001) is preferred.
- Good documentation and organizational skills.
- Detail-oriented with the ability to follow instructions and standard operating procedures.
- Responsible
- 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
For more information on SHL Medical, please visit: shl-medical.com