Are you passionate about optimizing manufacturing systems and ensuring quality compliance in a fast-paced, regulated environment? My client, a leading medical device company, is seeking an MES Quality Engineer II to drive continuous improvement and support the implementation of Manufacturing Execution Systems (MES). This is your chance to be a key player in a global organization that impacts patient care worldwide.
Why You Should Apply
- Be a crucial part of a team ensuring seamless MES deployments and optimizations.
- Work in a cutting-edge medical device manufacturing environment.
- Opportunity to lead validation efforts and maintain compliance in a regulated industry
- Comprehensive benefits: 401(k) match, health/dental/vision, paid time off, parental leave, tuition reimbursement, and more.
What You’ll Be Doing
- Support MES deployments, upgrades, and optimizations to improve manufacturing processes.
- Maintain compliance of MES systems and integrity of the electronic device history record (eDHR).
- Develop and revise MES documentation, procedures, and validation test cases.
- Collaborate with IT, Operations, and Engineering to enhance system functionality.
- Train employees on MES processes and best practices.
About You
- Be able to do the job as described.
- Strong knowledge of 21 CFR 820, ISO 13485, and FDA medical device regulations.
- Experience with Computer System Validation (CSV) and Change Management.
- Familiarity with MES implementation and maintenance in a regulated setting.
- Excellent problem-solving and communication skills.
How To Apply
We’d love to see your resume, but we don’t need it to have a conversation. Send an email to ccupo@jacobsmgt.com and tell me why you’re interested. Or, if you do have a resume ready, apply here.