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Operations Leadership
2 months ago
This is an Operations leadership role in our new state-of-the-art device manufacturing facility. The Operations Leadership - Night Shift will provide oversight and leadership for all departments on their assigned shift, including Manufacturing, Facilities, Supply Chain, and Quality.
Main Responsibilities- Provide Health, Safety, and Environmental (HSE) and Quality leadership for all departments on assigned shift.
- Provide leadership and coaching to department Supervisors.
- Act as the primary liaison between night shift operations and daytime management, ensuring seamless communication and collaboration.
- Support Site Leadership to build a diverse and capable site organization based on engineering first principles and operational excellence.
- Quickly address and resolve operational issues that arise during the night shift, making critical decisions to maintain workflow and productivity.
- Plan, coordinate, and manage cost-effective production strategies for assigned shift to meet production cost targets, schedules, and quality control standards.
- Ensure strict adherence to current Good Manufacturing Practice (cGMPs), established manufacturing practices and procedures, and compliance with Quality regulations and guidelines.
- Ensure operations and practices comply with established procedures and records.
- Support evaluation, specification, installation, and validation of new manufacturing equipment as needed.
- Incorporate value improvement programs and new processes from Engineering, EH&S, and OE as directed.
- Serve as project member or project leader on improvement programs as needed.
- Perform all job duties and responsibilities in a compliant and ethical manner and by all applicable healthcare laws, regulations, and industry codes.
- Bachelor's Degree in Engineering, Business, Operations Management, or relevant concentration preferred.
- Minimum 5 years relevant industry experience, strongly preferred in high-volume plastic and metal component assembly and production management/assembly automation and inspection technology.
- Relevant experience in managing high-volume manufacturing, including material logistics, equipment maintenance, and quality management.
- Several years of hands-on manufacturing experience in a 24/7 high-volume production setting.
- Proven experience leading and managing teams in a high-pressure, fast-paced manufacturing environment.
- Passionate and committed self-starter with a 'can do' attitude, team player, and taking responsibility to get the job done.
- Ability to work independently with strong attention to detail and focus on efficiency, effectiveness, and cost.
- Willingness to work from/relocate to Charleston, South Carolina is required.
- Excellent intercultural and interdisciplinary communication skills; Good at building a professional network.
- Previous exposure to a highly regulated industry (e.g., medical, pharmaceutical) and knowledge of relevant standards (e.g., ISO13485, cGMP) is a major plus.
- Experience with green field, or startup environment.
- Experience within the Manufacturing, Medical Device, Pharmaceutical, or Biotechnology industry.
- Experience in developing and implementing new processes or automating current processes.
- Willingness to initially spend an extended period in our facility in Taiwan for induction/training.
- 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.