- Supports formulation build of products.
- Supports preparation and verification of components.
- Follows SOP requirements for cleaning, labeling, and sealing of processed units.
- Supports ERP move and material transactions are completed timely.
- Follow Company policies and procedures compliance.
- Properly transfer and stock supplies for all controlled areas ( autoclave, clean room and quality areas)- complete system transactions where applicable (for inventory control purposes)
- Supports ERP move and material transactions are completed timely.
- Assist with final packaging activities, such as but not limited to, kitting and prepping lots.
- Assist in main clean room activities, as required
- Assist in organizing delivered gowning supplies from approved vendor and stocking of gowning supplies in the Gowning Room.
- Assist in performing waste water treatment for proper disposal.
- Assist with daily general cleaning and performs other job duties as assigned.
- Perform other job duties as assigned
- High School Diploma or equivalent required
- 0 – 2 of experience in an FDA-regulated manufacturing environment, preferably in a Medical Device manufacturing environment
- Mathematical skills
- Knowledge of Good Manufacturing Practices (GMP)
- Individual must be punctual and have reliable attendance
- Individual must be cooperative and willing to work in a team environment
- Must be able to follow direction provided by authorized supervision
- Must have the ability to multi-task in a fast-paced environment
- Must be willing to learn different jobs in the manufacturing environment
- Must be able to perform repetitive task(s) consistently and proficiently
- Must be able to speak and read English with excellent understanding
- Must be able to keep legible and correct documentation of activities
- Must be proficient in tasks performed (after suitable training period) and have attention to detail
- Ability to utilize a computer, telephone, label printer and copy machines as well as other general office equipment.
- Ability to work overtime, including evenings, weekends and holidays
- Knowledge of Lean Manufacturing and Six Sigma Green or Black Belt
- Knowledge of Quality System Regulation (QSR) and International Organization for Standardization (ISO)
- Medical device manufacturing/assembly/packaging experience
- Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better)
- Oracle ERP experience
- This position may require some standing.
- This position may require some bending, stooping, kneeling, or crouching.
- This position may require some walking.
- This position requires frequent or continuous moderate lifting of 15-40lbs.
- This position requires frequent or continuous pushing and/or pulling.
- This position requires frequent or continuous repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers.
- This position may require some exposure to dust, fumes, gases, odors or other airborne irritants.
- This position requires frequent or continuous exposure to chemicals and/or solvents.
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Manufacturing, Process Technician I - Irvine, United Kingdom - Orthofix
1 week ago
Description
Why Orthofix?
We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning
Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun
JOB PURPOSE
The technician is responsible for prepping and packaging of supplies to support the build plan and forecast demands. Assisting Manufacturing Supervisor / Manager in overseeing production team to ensure all production operations are in compliance with SOP's, current GMPs, QSR, GTP, and ISO standards as well as company procedures.
3rd Shift Hours: 9:00pm - 5:30am.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
MINIMUM QUALIFICATIONS
Education/Certifications:
Experience, Skills, Knowledge and/or Abilities:
PREFERRED QUALIFICATIONS
Education/Certifications:
Additional Experience, Skills, Knowledge and/or Abilities:
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
The anticipated base hourly rate for an employee who is located in California for this position is $ to $ per hour, plus bonus, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer and this pay scale may not reflect the pay scale for an employee who works in other states or locations.
DISCLAIMER
