- Maintaining Process Driven movement with strict adherence to safety and process procedures.
- Assist with the implementation of QMS to obtaining ISO 13485 site certification for SHL in Charleston, SC with oversight of one or more of the below QMS functions:
- Processes and releases controlled documents in the SHL electronic Document Control system.
- Processes and controls storage of Quality Records including electronic and hardcopy documents.
- Reviews format and conformance necessities to documents; including but not limited to signature, dating and Good Documentation Practice.
- Assists in designing and maintaining training matrices.
- Support compilation and presentation of Management Review meeting documentation package
- Conducts internal and supports external audits as assigned to ensure compliance to company quality systems requirements.
- Additional Responsibilities may Include: Support Material Review Board, Support Change Request & review board
- Associate degree in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry
- Knowledge of ISO 13485
- Knowledge of and ability to use process management tools
- Customer orientation and the ability to identify and effectively manage stakeholder expectations
- Ability to prioritize and to thrive in a cross-functional, inter-company and international environment
- A solution-oriented growth mindset
- Fluent in English language, written and spoken
- Team player and self-starter, able to perform with minimal supervision
- 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
-
QMS Specialist
1 week ago
SHL Medical West Columbia, United StatesSHL Medical AG is a 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 innovativ ...
-
Quality Assurance Specialist II
2 days ago
EPM Scientific South Carolina, United StatesQuality Assurance Specialist II · Location: Greenville/Spartanburg/Anderson Area, SC · Working Situation: Onsite · Level: Associate Level · Our client is a global medical device company who is the industry leader of new product development. Our innovative company is actively sear ...
-
Specialist, Food Safety
2 weeks ago
Hojeij Branded Foods, Inc. Columbia, United States Full timeThe Mark Anthony Group of Companies is one of North America's most diversified and successful private beverage companies focused on the alcohol beverage sector. Founded in 1972, the Company grew organically from a one-man wine importing business to a producer and distributor of f ...
-
Customer Experience Specialist, POC
1 day ago
SC Works Trident West Columbia, United StatesHere are the details for the selected job. You may need to scroll down to see all the information about the job, including the job description. If you wish to apply for this job click on the Apply button. · Customer Experience Specialist, POC - South Carolina · Siemens Healthcar ...
-
Customer Experience Specialist, POC
2 days ago
SC Works Trident West Columbia, United StatesHere are the details for the selected job. You may need to scroll down to see all the information about the job, including the job description. If you wish to apply for this job click on the Apply button.Customer Experience Specialist, POC - South Carolina Siemens Healthcare Diag ...
-
Customer Quality Support Advisor
2 days ago
Australianterminals Washington, United StatesATOM specialises in managing and operating bulk fuel terminals across Australia for our customers, with services ranging from storage and handling of bulk liquid fuels to maintenance and engineering. · Our team is made up of a great network of experts with a wealth of experience ...
-
Quality Control Specialist
6 days ago
CGI Group, LLC Washington, United StatesQuality Control Specialist (Junior - Senior) · Position Description · CGI Federal is seeking Quality Control (QC) Specialists who will be responsible for the daily monitoring of the Quality Management System (QMS) processes and performing QC checks in all functional areas. The Q ...
-
Quality Assurance
1 week ago
ManTech International Corporation Washington, United StatesSecure our Nation, Ignite your FutureBecome an integral part of a diverse team while working at an Industry Leading Organization, where our employees come first. At ManTech, you'll help protect our national security while working on innovative projects that offer opportunities fo ...
-
Quality Assurance
2 weeks ago
ManTech International Corporation Washington, United States Full timeSecure our Nation, Ignite your Future · Become an integral part of a diverse team while working at an Industry Leading Organization, where our employees come first. At ManTech, you'll help protect our national security while working on innovative projects that offer opportunities ...
-
Quality Training Manager
1 week ago
Selkirk Pharma Washington, United StatesSelkirk Pharma is seeking a proactive, quality-driven individual for our Quality Training Manager role. The right candidate has experience in Biotech/Pharma cGMP with an emphasis in a regulated training environment as this role supports the development of the Training program for ...
-
Quality Assurance
1 week ago
ManTech International Corporation Washington, United StatesSecure our Nation, Ignite your FutureBecome an integral part of a diverse team while working at an Industry Leading Organization, where our employees come first. At ManTech, you'll help protect our national security while working on innovative projects that offer opportunities fo ...
-
Quality Assurance Specialist
1 week ago
Cambrex Washington, United StatesInformazioni sulla location: · Nello stabilimento di Paullo siamo in grado di sviluppare e produrre Principi Attivi Farmaceutici (API) generici e di marca e intermedi avanzati su scala commerciale. · La nostra gamma di prodotti comprende oltre 80 API generici prodotti secondo g ...
-
Quality Compliance Specialist
6 days ago
Palantir Technologies Washington, United StatesA World-Changing Company · Palantir builds the worlds leading software for data-driven decisions and operations. By bringing the right data to the people who need it, our platforms empower our partners to develop lifesaving drugs, forecast supply chain disruptions, locate missin ...
-
Quality Compliance Specialist
1 week ago
Palantir Technologies Washington, United StatesA World-Changing Company · Palantir builds the world's leading software for data-driven decisions and operations. By bringing the right data to the people who need it, our platforms empower our partners to develop lifesaving drugs, forecast supply chain disruptions, locate missin ...
-
QA Operations Specialist II
1 week ago
Selkirk Pharma Washington, United StatesSelkirk Pharma is seeking a QA Operations Specialist II. This position is primarily responsible for providing Quality on-the-floor oversight of manufacturing activities, deviations, CAPAs, and change controls. This role works closely with operations, facilities, and parallel qual ...
-
QA Operations Specialist II
4 days ago
Selkirk Pharma Washington, United States· Selkirk Pharma is seeking a QA Operations Specialist II. This position is primarily responsible for providing Quality on-the-floor oversight of manufacturing activities, deviations, CAPAs, and change controls. This role works closely with operations, facilities, and parallel q ...
QMS Specialist - South Carolina, United States - SHL Medical
Description
SHL Medical AG is a 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 Unites States.
Job Overview/Objective
The position of the QMS Specialist participates in maintaining the Quality Management System (QMS) at the SHL Medical Charleston site. Ensures all relevant internal and external departments comply to the SHL QMS including certifications and regulatory requirements. Collaborates with regional and global counterparts to ensure consistency of processes. Effectively works with local and global employees to ensure regulatory compliance.
Main Responsibilities
Skills and Qualifications
We Offer
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 -
For more information on SHL Medical, please visit:
Is this not quite what you are looking for? Further interesting career opportunities can be found on: shl-
Please note: We do not consider applications from recruitment agencies for this position.