LEAD3R is looking to speak with Quality Control Managers who are interested in joining a global industry leading medical device manufacturing organization. This is an on-site, direct-hire opportunity at my clients state-of-the-art facility in Charleston, SC.
The Quality Control Manager will be responsible for ensuring the effectiveness and quality of products tested in the QC Lab. They will also oversee the investigation and execution of non-conforming material (NCMR) processes, complaint handling processes, and continuous improvement initiatives at the facility. The successful candidate will lead a team focused on these activities and ensure that appropriate tools, techniques, and methodologies are used in compliance with company standards and applicable regulations.
Key Responsibilities
- QC Lab Oversight: Oversee the daily operations of the QC Lab, including team assignments, project management, equipment qualification, and test method development.
- Project Management: Develop and manage project plans to ensure successful completion of deliverables.
- Risk Management: Identify and mitigate risks, develop alternative solutions, and resolve issues in collaboration with cross-functional teams.
- Lab Operations: Plan and lead the execution of laboratory activities to support supply chain and processes, adhering to regulatory requirements.
- Metrics Monitoring: Track and report on QC Lab metrics to assess performance and identify areas for improvement.
- Investigations: Facilitate team investigations to ensure compliance with quality and regulatory requirements.
- Continuous Improvement: Drive continuous improvement initiatives, such as Lean Six Sigma, to optimize lab processes.
- Complaint Handling: Implement and oversee the complaint handling process, ensuring timely investigation and resolution.
- NCMR Management: Manage the NCMR process, including investigation and corrective action.
- Team Leadership: Manage a team of 3 (QC Lab Supervisor and 2 QA Engineers) and oversee Quality Operations resources.
Qualifications
- Bachelor's degree in science or engineering (e.g., mechanical, industrial, biomedical, chemical engineering, material/life science).
- At least 5 years of experience in a regulated environment (medical devices/diagnostic instrumentation industry, pharmaceutical or biotechnology industry).
- Experience with modular automation/fully automated assembly processes, especially those involving plastic injection molded parts and mechanical springs.
- Knowledge of test method validation and transfer.
- Familiarity with cGxP regulations, including ISO 13485, FDA 21 CFR 820, and MDD 93/42/EEC.
- Proficiency in statistical methods.
- Strong attention to detail.
If you or someone you know may be interested, please send your resume to ...@Lead3r.com or visit Lead3r.com to learn more about us. #LifeSciences #LEAD3Rjobs #LEAD3R