Quality Control Manager

Quality Control Manager

Location: Charleston, South Carolina, US onsite role

Full time.

Have to be flexible maybe somedays they may have to come in off hours to cover some of their indirect reports
Only medical device experience will do
Deal with machines and math and what the FDA and customers are expecting
Measurement testing, medium to large company
Must be a manager seasoned walking into a large organization
QC Lab has to be spotless everything has to be in order down to the cords and where they are place
Do not want pharmaceutical background mid November start
fully-onsite
Interim person who is doing this has no medical device exp.
Int Process

Have one person coming in Thursday they are high on but want other candidates to compare

Want someone with medical device experience

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 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 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 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 a team 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.