Job Title
We are seeking a skilled Manufacturing Production Specialist to join our team.
Key Responsibilities:
* Production Support: Provide technical support to the manufacturing line, ensuring prompt resolution of equipment, tooling, process, or material issues.
* Equipment Management: Perform routine and preventative maintenance on equipment to ensure optimal function and reliability.
* Continuous Improvement: Identify and implement improvements to processes, jigs, and methods that enhance product quality and overall efficiency.
* Quality & Compliance: Maintain accurate documentation in compliance with GMP, ISO 13485, FDA, and MDR requirements.
* Project & Validation: Assist the Engineering team with process development, verification, and validation testing for new and existing products.
* Teamwork & Training: Collaborate effectively with cross-functional teams during line validations and support product builder training on new work instructions.
Essential Experience & Qualifications:
* Experience: 2-5 years of hands-on technical experience working in the Medical Device or regulated Pharmaceutical/Cleanroom industry.
* Technical Knowledge: Proven experience operating and maintaining complex production equipment and supporting process improvement initiatives.
* Compliance: Working knowledge of QMS requirements, including ISO 13485, EU MDR, and FDA regulations.
* Skills: Demonstrated ability to read and interpret technical drawings, process diagrams, and equipment manuals.
* Key Attributes: Problem Solver: Excellent ability to troubleshoot and problem-solve quickly under pressure. Autonomous: Takes ownership of responsibilities and can work effectively in a team setting or autonomously as required. Detail-Oriented: Excellent documentation practices (GDP) and attention to detail. Aptitude: Passionate about manufacturing methodologies (Lean/Six Sigma) and continuous improvement.