Contingent Worker - MFG Process Technician

Quest Oracle Community; Irvine, Northern (CA, KY); Hybrid; USD 45,000 - 65,000; Full time

Job summary

Orthofix in Irvine, CA is seeking a Contingent Worker for the MFG Process Technician role. You will support formulation build, prep components, and ensure production operations comply with SOPs, GMPs, QSR, ISO, and company procedures.

The role requires a High School diploma, GMP knowledge, math skills, and the ability to multi-task in a fast-paced environment. You will work with supervisors, assist in clean room activities, packaging, and maintain accurate documentation.

Qualifications

• High School Diploma or equivalent required.
• Experience in an FDA-regulated manufacturing environment, preferably medical devices.
• Math skills are required.
• Knowledge of GMP is required.
• Punctuality and reliable attendance are essential.
• Must be able to work in a team environment.
• Ability to follow directions from supervision.
• Ability to multi-task in a fast-paced environment.
• Must read and understand English.
• Accurate documentation of activities required.

Responsibilities

• Support formulation build of products.
• Prepare and verify components.
• Follow SOP requirements for cleaning, labeling, and sealing of processed units.
• Support ERP move and material transactions are completed timely.
• Adhere to company policies and procedures.
• Transfer and stock supplies for controlled areas and complete system transactions.
• Assist with final packaging activities (kitting, prepping lots).
• Assist in main clean room activities as required.
• Organize gowning supplies and stocking in Gowning Room.
• Perform waste water treatment for proper disposal.
• Daily general cleaning and other duties as assigned.
• Overtime may be required.

Skills

Math skills

GMP knowledge

Punctuality

Teamwork

Multi-tasking

Follow directions

Willing to learn

English literacy

Education

High School Diploma or equivalent

Tools

Oracle ERP

Lean Six Sigma

QSR/ISO knowledge

Job description

Position Title: Contingent Worker - MFG Process Technician

Location: Irvine

Position Type: Full time

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

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

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

• 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.

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