Position Title:Contingent Worker - MFG Process Technician
Location: Irvine
Position Type: Full time


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:

• 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)

Additional Experience, Skills, Knowledge and/or Abilities:

• 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.

About Us:

Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.

Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.

Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.

Equal employment opportunity, including veterans and individuals with disabilities.

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