Why Orthofix?
Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the partner in Med Tech.
Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.
JOB PURPOSE
The technician is responsible for the demineralization process and assists in completing the build plan and forecast demands. Responsible for critical equipment (used for demineralization) and promotes a team environment. The technician is responsible for ensuring all demineralization operations comply with SOP's, current GMPs, QSR, GTP, and ISO standards as well as company procedures.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
1. Follow company policies and compliance procedures.
2. Support preparation and verification of components, tools, and equipment.
3. Support formulation build of products.
4. Follow SOP requirements for cleaning, labeling of processed items and equipment teardowns after processing is completed.
5. Assist in organizing delivered gowning supplies from approved vendor and stocking of gowning supplies in the Gowning Room.
6. Support the demineralization process & activities as scheduled by the Line Lead and Supervisor.
7. Prepare and weigh out NDBM/NDBF per the work instruction.
8. Setup and assemble demineralization vessels, tools, equipment, and workstations.
9. Prepare water and acid for NDBM/NDBF.
10. Perform visual check of HCL, buffer, and RO/DI Water for each station prior to start of process as well as during the process, to ensure chemical levels are to specifications.
11. Setup the Laminar Airflow stations for post demineralization activities.
12. Transfer demineralized DBM to trays, label, and load trays into freezer.
13. Support ERP move and complete material transactions.
14. Assist with review of manufacturing related documentation.
15. Monitor HCL, buffer, NDBM/NDBF inventory and submit Kanban cards when appropriate.
16. Assist with general daily cleaning, restocking supplies, daily environmental/equipment monitoring in Demin area and cleanroom. Perform system transactions where applicable.
17. Assist in main clean room activities as required and perform other duties as assigned.
MINIMUM QUALIFICATIONS
Education/Certifications:
18. High School Diploma or equivalent required
Experience, Skills, Knowledge and/or Abilities:
19. 0-1 of experience in an FDA regulated manufacturing environment
20. Individual must be punctual and have reliable attendance
21. Strong mathematical skills
22. Knowledge of Good Manufacturing Practices (GMP), Quality System Regulation (QSR) and International Organization for Standardization (ISO)
23. Individual must be cooperative and willing to work in a team environment
24. Must be able to follow direction provided by authorized supervision
25. Demonstrates ability to adapt to fast-paced, team-oriented work environment
26. Ability to analyze, troubleshoots, and resolves problems/issues as they arise
27. Must be willing to learn different jobs in the manufacturing environment
28. Must be able to perform repetitive task(s) consistently and proficiently
29. Must be able to speak and read English with excellent understanding
30. Must be able to keep legible and correct documentation of activities
31. Must be proficient in tasks performed (after suitable training period) and have attention to detail
32. Ability to utilize a computer, telephone, label printer and copy machines as well as other general office equipment.
33. Ability to work overtime, including evenings, weekends, and holidays
PREFERRED QUALIFICATIONS
Education/Certifications:
34. Associate Degree in a technical or science discipline preferred.
35. Basic understanding of Lean Manufacturing and Continuous Improvement
Additional Experience, Skills, Knowledge and/or Abilities:
36. Uphold teamwork, excellent communication and interpersonal skills
37. Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better)
38. Experience in a Medical Device manufacturing environment
39. Oracle ERP experience
40. Agile Product Lifecycle management software
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
41. This position may require some standing.
42. This position may require some bending, stooping, kneeling, or crouching.
43. This position may require some walking.
44. This position requires frequent or moderate lifting of 15-40lbs.
45. This position requires frequent or continuous pushing and/or pulling.
46. 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.
47. This position may require some exposure to dust, fumes, gases, odors, or other airborne irritants.
48. 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 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