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
1. Supports formulation build of products.
2. Supports preparation and verification of components.
3. Follows SOP requirements for cleaning, labeling, and sealing of processed units.
4. Supports ERP move and material transactions are completed timely.
5. Follow Company policies and procedures compliance.
6. Properly transfer and stock supplies for all controlled areas ( autoclave, clean room and quality areas)- complete system transactions where applicable (for inventory control purposes)
7. Supports ERP move and material transactions are completed timely.
8. Assist with final packaging activities, such as but not limited to, kitting and prepping lots.
9. Assist in main clean room activities, as required
10. Assist in organizing delivered gowning supplies from approved vendor and stocking of gowning supplies in the Gowning Room.
11. Assist in performing waste water treatment for proper disposal.
12. Assist with daily general cleaning and performs other job duties as assigned.
13. Perform other job duties as assigned
MINIMUM QUALIFICATIONS
Education/Certifications:
14. High School Diploma or equivalent required
Experience, Skills, Knowledge and/or Abilities:
15. 0 – 2 of experience in an FDA-regulated manufacturing environment, preferably in a Medical Device manufacturing environment
16. Mathematical skills
17. Knowledge of Good Manufacturing Practices (GMP)
18. Individual must be punctual and have reliable attendance
19. Individual must be cooperative and willing to work in a team environment
20. Must be able to follow direction provided by authorized supervision
21. Must have the ability to multi-task in a fast-paced environment
22. Must be willing to learn different jobs in the manufacturing environment
23. Must be able to perform repetitive task(s) consistently and proficiently
24. Must be able to speak and read English with excellent understanding
25. Must be able to keep legible and correct documentation of activities
26. Must be proficient in tasks performed (after suitable training period) and have attention to detail
27. Ability to utilize a computer, telephone, label printer and copy machines as well as other general office equipment.
28. Ability to work overtime, including evenings, weekends and holidays
PREFERRED QUALIFICATIONS
Education/Certifications:
29. Knowledge of Lean Manufacturing and Six Sigma Green or Black Belt
30. Knowledge of Quality System Regulation (QSR) and International Organization for Standardization (ISO)
Additional Experience, Skills, Knowledge and/or Abilities:
31. Medical device manufacturing/assembly/packaging experience
32. Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better)
33. Oracle ERP experience
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
34. This position may require some standing.
35. This position may require some bending, stooping, kneeling, or crouching.
36. This position may require some walking.
37. This position requires frequent or continuous moderate lifting of 15-40lbs.
38. This position requires frequent or continuous pushing and/or pulling.
39. 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.
40. This position may require some exposure to dust, fumes, gases, odors or other airborne irritants.
41. This position requires frequent or continuous exposure to chemicals and/or solvents.
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