Applying ISO 14971:2019 and working with device risk management files to represent Global Quality Engineering in all Design Controls and Product Development related aspects

The Operations PMO Analyst at our North Charleston site shall support the site leadership team in activities related to generation, tracking, and analyzing of site projects and operations key performance indicators with relevant process owners.

The Quality Control Manager is responsible for supporting the effectiveness and quality of product tested in Quality Control (QC) Lab, effective investigation and execution of the non-conforming material (NCMR) process, effective investigation and execution of the complaint handling process, and continuous improvement activities at in the SHL Medical in North Charleston SC.

The Spare Parts Clerk is responsible for performing storerooms and inventory-related tasks proficiently and accurately. Will maintain appropriate spare parts inventory level to avoid equipment downtime when maintenance is required. This role will work closely with a cross-functional team.

The Manufacturing Operator Safely loads material and operates assembly equipment according to the procedure.

The PMO (Project Management Office) Analyst is responsible for supporting Head Global PMO in activities related to managing, analyzing, and tracking project portfolios and project management processes in line with the overall corporate strategy.

The Occupational Health Nurse will provide direct care services to employees on the job.

The Quality Control Supervisor will lead the QC team and is responsible for overseeing all aspects of our quality control operations, ensuring that our products meet the highest standards. This role will supervise a team of QC inspectors and technicians, develop and implement quality control procedures, and ensure compliance with all relevant regulations.

The IT/OT Service Desk Specialist is responsible for providing technical support and exceptional customer service to our internal employees and external clients in the office and shop floor (OT) environments.

The Night Shift Supervisor – Device Assembly will be a key team member in supporting the start-up and continued success of the Device Assembly Operations at a newly constructed state-of-the-art facility located in North Charleston SC. 

The Supply Chain Coordinator will assist with customers’ operational demands and oversee customer transactions. This person will also be responsible to support the site Sales and Operations Planning process by providing support on business growth and capacity assessment. 

The Materials Handler position is responsible for movement of material and operation of Material movement equipment in the building by performing the following duties.

This is an Operations leadership role in of our new state-of-the-art device manufacturing facility in North Charleston, South Carolina. The Superintendent will provide oversight and leadership for all departments on their assigned shift.

This role is embedded in the Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina. Together with the rest of your team, you will drive and support manufacturing automation, with a particular focus on software, data handling, and digital systems.

This role is embedded in the Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina. Together with the rest of your team, you will drive and support manufacturing automation, with a particular focus on assembly processes and automated production equipment.

The Quality Engineering Senior Manager position is primarily responsible for overseeing Design Control and Risk Management activities that apply to product and process development lifecycles led by US Design Office. Projects that are Design Control specific may include New Product and Process Design/Significant Design Changes to Existing Product Business Scale-up Projects (eg: New Automation Lines, New Injection Molding Toolsets, New metal processing lines). This position may also lead or support Quality functional initiatives (eg: PEC- Predictability, Efficiency and Compliance Projects) as well as improvement activities (eg: Continuous Improvements projects). This position is accountable for delivering high reliability and quality products through efficient execution of Design Control governance, inculcate the culture of statistically robust, data-driven decision-making process, and meeting quality objectives/metrics for the business. This position is also responsible for ensuring that the product and process development activities are in compliance with all applicable internal, corporate, and regulatory standards or requirements. This position will involve staffing, developing, and resource planning for Quality Engineers for the US Design Office.  Additionally, this role may serve as a Quality Core Team member on new product/process development efforts or other Projects which are linked to corporate strategic imperatives.

This role is embedded in the Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina.

To perform all maintenance and operations of SHL medical device manufacturing facilities. Responsible for ensuring the smooth operation of all equipment and machinery in the facility.

As a Tooling & Maintenance Technician at SHL Medical's Charleston facility, you'll be integral to our injection molding operations, focusing on the meticulous assembly, disassembly, and maintenance of plastic injection molds.

Develops, establishes, and maintains the quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulatory agency guidelines to ensure continued customer satisfaction.

The Materials Handler position is responsible for movement of material and operation of Material movement equipment in the building by performing the following duties.

We are looking for an experienced Warehouse Lead to coordinate and oversee the daily operations. The successful candidate will be responsible for ensuring that orders are filled accurately and in a timely manner, that the warehouse is organized and safe, and that staff members are supervised and trained.

The Production Technicians primary responsibility will be to ensure our Fully Automated Assembly Machines are operating with minimal waste and as efficiently as possible.

The Machine Maintenance Specialist will focus on implementing predictive maintenance technologies on the central facility and production equipment in a highly automated medical production facility. Also, assist in troubleshooting and repairing all equipment within the facility from air compressors to injection molding machines as needed to help reduce equipment downtime.

The Facilities Maintenance Manager is responsible for ensuring the maintenance of all facilities equipment.

The main responsibilities of the Injection Mold Specialist Technician are Maintenance and troubleshooting activities on Engel Injection Molding Machines. Be responsible for ensuring the smooth operation of all the Injection Molding Machine in the facility

The Project Manager is in charge of the successful implementation of a specific project within SHL Medical. He/she will work closely with all team members to ensure, that project requirements, deadlines, and schedules are always on track. Overall responsibilities are planning, budgeting, resource allocation as well as project risk management, and project team leadership. The Project Manager will be responsible for managing major/complex projects and leading various disciplines in executing the required deliverables under a highly regulatory/GMP environment. It is expected that these projects require disciplined leaders and multiple team interfaces. The ability to interact with customers, internal stakeholders, and cross-functional team leads from project initiation through the entire design and development process is a must.

The Design Engineer carries out development activities for medical devices, including design, prototyping, technical analyses, and testing. The Design Engineer collaborates closely with cross-functional project teams to ensure that designs meet user needs, and quality requirements, and consider manufacturability. The Design Engineer will communicate directly with customers and manufacturing teams and will be required to travel >10% of the time. The Design Engineer will also support regulatory filings for combination products.

The Manufacturing Process Engineer will support the automated production of sub-components, packaging materials, and assemblies for our autoinjector systems.

The CI Manager will work with SHL’s Charleston & Deerfield site’s different business functions within the organization to improve manufacturing, operations processes, and other functions’ efficiency using lean methodology concepts and other improvement tools.

The LPTs will be the resident mechanical experts who have full responsibility, on their assigned shift, for the fully automated assembly line for which they are responsible.

This role is embedded in Production / Injection Molding of our new state-of-the-art device manufacturing facility in North Charleston, South Carolina.

The SAP Business Analyst will optimize SHL Medical’s business processes by analyzing current processes, collaborating with management on SAP integration, and overseeing the implementation of SAP solutions.

The Senior MES Software Engineer will be an integral member of the PLM/MES&IT-OT team pushing technical advancement of the manufacturing execution system.