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, …
Skills: Manufacturing, Medical device assembly, Packaging, GMP, QSR
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Full-time
high school
Posted 2d ago
~40 hrs/week
Responsibilities
The technician is responsible for prepping and packaging supplies to support production build plans and forecast demands. They assist in overseeing production operations to ensure compliance with GMP, QSR, and ISO standards.
Requirements
Candidates must have a high school diploma or equivalent and 0-2 years of experience in an FDA-regulated manufacturing environment. Proficiency in documentation, attention to detail, and the ability to perform repetitive tasks in a fast-paced environment are required.
Full job description
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 unrivaled 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 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.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
The following are the essential functions of this position. This position may be responsible for performing additional duties as tasks as needed and assigned.
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 (i.e. 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
MINIMUM QUALIFICATIONS
The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.
Education/Certifications:
High School Diploma or equivalent required
Experience, Skills, Knowledge and/or Abilities:
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
PREFERRED QUALIFICATIONS
The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.
Education/Certifications:
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
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.
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.
DISCLAIMER
The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status.
DISCLAIMER
The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.
This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
Orthofix is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, we deliver exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, specialized limb reconstruction solutions, biologics and enabling technologies, including the 7D FLASH™ navigation system.
𝗢𝘂𝗿 𝗩𝗶𝘀𝗶𝗼𝗻:
To be the unrivaled partner in MedTech, delivering exceptional experiences and life-changing solutions.
𝗢𝘂𝗿 𝗠𝗶𝘀𝘀𝗶𝗼𝗻:
We provide medical technologies that heal musculoskeletal pathologies. We enable our teams through opportunities for growth, ownership of responsibilities, and empowerment to execute. We do this for patients and the healthcare professionals who treat them. We collaborate with world-class surgeons and other partners to bring to market highly innovative, cost-effective, and user-friendly medical technologies through excellent customer service. We do this to improve people’s quality of life and, in doing so, create exceptional value for our customers, employees, and stockholders.
𝗢𝘂𝗿 𝗩𝗮𝗹𝘂𝗲𝘀:
• Take Ownership
• Innovate Boldly
• Win Together
Join our mission to revolutionize musculoskeletal care and be a part of innovation that changes lives. Start your journey now at https://orthofix.com/about/careers/.
Offices: 3451 Plano Parkway, Lewisville, TX 75056, US · Via delle Nazioni, 9, Bussolengo, Veneto 37012, IT · 501 Mercury Drive, Sunnyvale, CA 94085, US · Alameda Santos 1978, Conj 162, 16°andar, Sao Paulo, BR 01418-102, BR · 6 Waltham Road, Waltham Park, White Waltham, Maidenhead, England SL6 3TN, GB
BioStim - Bone growth devices for enhancing bone fusionBiologics - Regenerative tissue forms to facilitate bone fusionLimb Reconstruction ProductsSpine Fixation - Solutions for surgeries of the spineSpine FixationBiologicsBone Growth TherapiesComplex Fracture ManagementExtremity Deformity CorrectionLimb Preservation
Based on 1207 listings with disclosed salaries, most engineering jobs in Irvine, CA pay between $43k–$187k per year. Individual offers vary with seniority, company size, and specialization.
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