DirecciónES S ENTIAL DUTIES & RESPONSIBILITIES:
Ensure that manufacturing operations follow all Good Manufacturing Practices and Procedures as defined by Nordson Medical’s polices. Ensure that FDA and Quality Standards are met.
- Supervises personnel and maintains harmony and communication between team members. At the same time, the line chief is responsible for disciplinary action when necessary.
- Ensures that all equipment, fixtures, tools, gauges, ext. have complete maintenance and inspection records prior to beginning a new manufacturing order.
- Responsible for taking equipment, fixtures, ext. out of service and contacting maintenance when a problem is identified.
- Ensures that the Production Operators meet production standards, defined by engineering, as assigned per the parts per goal.
- Works under the supervision of the Sr. Production Supervisor and is required to follow his/her instructions.
- Uses and follows dress code procedures for work areas (such as Clean rooms and silicon area)
- Ensures all manufacturing orders are completed and available to ship on time by identifying and communicating any constraints that may cause a late order to the production supervisor.
- Ensures all employees have been trained to perform assigned operations prior to beginning a new manufacturing order.
- Is able to perform set-up changes for all manufacturing orders within the designated clean room. Is proficient in all manufacturing processes and procedures, including inspection within the designated operation areas.
- Is responsible for completing accurate production documentation by the end of each shift.
- Maintains a safe and healthy work environment by implementing, maintaining, and aligning company policies and procedures.
- Other duties or projects as assigned.
MINIMUM QUALIFICATIONS:
Required Education:
- High school education or higher is desirable.
- Prior experience and knowledge in Medical devices manufacturing is required.
- Understanding of common machines and assemblies, knowledge of molding operations is desirable.
- Related experience within international standards (ISO 13485 / 9001), FDA and European quality systems requirements (QSR, MDD), and risk management (ISO 14971, DFMEA and PFMEA) is desired.
- Up to 5 years in a maquiladora environment, in a similar position may be considered.
Knowledge, Skills & Abilities (KSA’s):
- Ability to be motivational and proactive in order to promote / create a positive and productive environment in the production team.
- Ability to communicate effectively with operators, partners, and supervisors.
- Basic math and metrology skills
- Have conciliatory skills in human conflicts.
- Ability to understand and solve mechanical problems.
- Ability to interpret drawings with medium degree of complexity.
- Ability to develop an understanding and practice of Nordson values and competencies.
- Values cultural diversity and other differences; fosters an environment where people who are culturally diverse can work together cooperatively and effectively in achieving organizational goals.
COMPUTER SKILLS:
- Understanding or basic knowledge on the use of some Microsoft Office Tools such as: Outlook, Word and Excel.
- Basic knowledge to read and interpret charts, graphs, and tables of information.
- Basic ERP skills.
PHYSICAL DEMANDS:
- While performing the duties of this job, the employee is regularly required to be stand, walk, and use hands and fingers, handle or feel, frequently required to talk, or hear, sit, reach with hands and arms, climb or balance, stoop, kneel and crouch.
- The employee must frequently lift and/or move up to 5 pounds, and occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required by this job include close vision.
- Ability to work in clean room environment, and use special gown, protection devices for ears and eyes at the same as gloves for hands.
