Location: Charleston, South Carolina, US
Reporting to: US Director, Quality
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.
Job Overview
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. This person must be able to lead a team focused on the activities defined above. The job holder ensures the applicable tools, techniques, and methodologies are used according to the company’s needs and applicable regulations.
Main Responsibilities
- Oversee the work of assigned team within the QC Lab including responsibilities on transfer, projects within manufacturing in collaboration with key stakeholders, oversee qualification of lab equipment, the development and validation of laboratory test methods in support of production and/or new product/process development.
- Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope, and objectives.
- Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups.
- Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards and guidelines.
- Lead in the monitoring and publishing of QC Lab metrics for the organization.
- Facilitate team to ensure laboratory specific investigations are performed in compliance with quality and regulatory requirements.
- Provide Quality Operations support in cross-functional workstreams leading to continuous improvement (e.g., Lean Six Sigma).
- Effectively transfer and implement the Complaint Handing process at SHL Medical North Charleston SC. Oversee the timely and effective execution of the complaint investigations. Lead in the monitoring and publishing of Complaint Process metrics for the organization.
- Effectively execute the non-conforming material (NCMR) process at SHL Medical North Charleston SC. Oversee the timely and effective execution of the NCMR investigations. Lead in the monitoring and publishing of NCMR Process metrics for the organization.
- Supervisory Responsibilities: Manage ateam of 3 ( 1 QC Lab Supervisor and 2 QA Engineers)Oversee Quality Operations resources that the QC Lab, NCMR process and Complaint Handling process for SHL Medical in the United States.
- Performs other related duties as assigned.
Skills and Qualification
- A Bachelor’s degree in science or engineering discipline (mechanical, industrial, biomedical, chemical engineering, material/life science) is required
- At least 5 years’ work experience in a in regulated environment (medical devices/diagnostic instrumentation industry, pharmaceutical or biotechnology industry)
- Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testing.
- Test method validation and transfer
- cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC
- Statistical methods
- Attention to detail.
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.
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents via the Easy Apply button or directly to RecruitUS@shl-group.com.
For more information on SHL Medical, please visit: linkedin.com/company/shlmedical/life
Is this not quite what you are looking for? Further interesting career opportunities can be found on: shl-medical.com/careers
- Please note: For this position, we do not consider applications from recruitment agencies.
