- Leads medium to large products that drive improvements in safety, quality, and value
- Manages risks, budget, schedules and resources to deliver the project successfully
- Collaborates with plant engineering, advanced engineering, production and other stakeholders to develop and maintain a high confidence roadmap of projects and associated value.
- Successfully manages outsourced mold and automation supplier relationships, ensuring requirements, terms and conditions are clearly aligned and met through to project completion.
- Partners with strategic sourcing, engineering, and maintenance to identify and evaluate potential suppliers as needed to deliver appropriate solutions.
- Ensures that all projects meet or exceed Haemonetics quality and safety standards.
- Clearly communicates team member expectations and project progress to all stakeholders.
- Ensuring that the EMS conforms to the requirements ISO 14001.
- Reporting the performance of EMS including environmental performance to top management
- Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.
- Perform other tasks as required.
- Bachelor's Degree in Engineering or technical discipline
- 5 years Manufacturing experience in the medical device industry
- and managing complex engineering projects within a team-oriented environment
- Expertise in manufacturing process control and process validation requirements, including statistical tools.
- Extensive knowledge and understanding of custom automation in the manufacture of plastic parts.
- Proficiency with practical knowledge in ISO 13485, FDA 21 CFR Part 820, EU Medical Device Directive requirements, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR 2017/745), Good Distribution Practice for Medical Devices (GDPMD).
- Experience with Six Sigma and Lean Manufacturing methodologies
Manufacturing Project Manager, Malaysia - Perai, Malaysia - Haemonetics
Description
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
Job Details
Responsible for cross functional leadership of medium to large manufacturing projects. Projects will typically involve the development, introduction, and validation of new molds, molding machines, and/or the addition or modification of automated assembly equipment in a medical device environment.
ESSENTIAL DUTIES
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Enter Responsibilities/Essential Duties
Requirement
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