Production Technician Autoclave I (Irvine)

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!

How you'll make a difference?

The Production Technician-Autoclave is responsible for completing manufacturing assignments as directed by the Manufacturing Manager and/or the Production Supervisor. Typical duties and tasks must be completed in compliance with the requirements of Standard Operating Procedures (SOP) per current GMP’s, QSR and company policies, laws and procedures.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties as tasks as needed and assigned.

Maintain the disinfection (steam autoclave) process to support manufacturing activities.Wash and/ or wrap equipment and supplies. Loading and unloading of drying oven and steam disinfection equipment. Place purchase requisitions for production spare parts and tooling, as necessaryVerify cycle printouts and logbooks. 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)Assist with final packaging activities, such as but not limited to, kitting and prepping lots.Assist in main clean room activities, as requiredAssist 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 disposalCompliant with company policies and proceduresAssist with daily general cleaning and performs other job duties as assigned.Perform other job duties as assigned

What skills and experience will you need?

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 years of experience in an FDA regulated manufacturing/controlled environment, preferably in a Medical Device Experience or human-tissue assembly/production.Must be able to speak, write and read English with excellent understandingAbility to adapt to a fast-paced environmentIndividual must be punctual and have reliable attendanceIndividual must be cooperative and willing to work in a team environmentMust be able to follow direction provided by authorized supervisionKnowledge of Good Manufacturing Practices (GMP)Ability to perform repetitive task consistently and proficientlyMust be able to interact with peers, Manufacturing Supervisor/ManagerMust be proficient in tasks performed (after suitable training period) and have attention to detailAbility to work overtime, including evenings, weekends and holidaysAbility to utilize a computer, telephone, label printer and copy machine as well as other general office equipment.

What qualifications are preferred?

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications

No additional requirements

Additional Experience, Skills, Knowledge And/or Abilities

Knowledge of Quality System Regulation (QSR) and International Organization for Standardization (ISO)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 frequent or continuous standingThis position may require some frequent or continuous bending, stooping, kneeling, or crouching.This position may require some frequent or continuous walking.This position may require some frequent or continuous moderate lifting of 15-40lbsThis position may require some frequent or continuous pushing and/or pulling.This position may require some repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers.This position may require some frequent or continuous exposure to dust, fumes, gases, odors or other airborne irritants.This position may require some 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 $17.41 to $19.24 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

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.