Position Title:Quality Control Technician III (2nd Shift)
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

QC Technician Ill is proficient performing inspections and testing at various stages of production of the product - from raw materials, sub-assemblies, and final assemblies to assure product quality and conformance to specifications and procedural requirements. QC Technician Ill analyzes problems, determines problem-solving techniques and exercises judgment in selecting appropriate solutions

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.

• Interprets engineering drawings, schematic diagrams to complete incoming, in-process and final inspections.
• Able to use a wide assortment of QC inspection instruments to assure components and devices are manufactured and functioning according to specification.
• Records test data and interpret its pass/fail status.
• Performs and documents all QA inspection and testing activities to assure conformance to specifications.
• Perform label inspections.
• Audits various manufacturing processes to assure compliance and product segregation.
• Monitors quality product in all stages of manufacturing and packaging process to determine proper sampling and variations in the process.
• Review donor records for compliance.
• Compiles and reviews device history records to assure compliance and releases products to Finished Goods
• Initiates non-conformance reports (NCRs) and follows-up to final disposition of nonconforming materials.
• Assists in developing and implementing Corrective and Preventive Actions (CAPA's) using known problem-solving techniques. Assists in developing and implementing Document Change Orders (DCO's)
• Redlines/revises specifications as needed, to assure QSR compliance.
• Trains other QC Technicians on new or revised procedures.
• Investigates and reports complaints on existing products as directed by QA Management.
• Fill out and process quality reports and entering into the computerized quality reporting database.
• Performs and/or assists special projects as directed by Quality Team Lead, Manager or Director.

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:

• 7 years or more related experience. Knowledge of GMPs (QSR) and/or ISO 9001 and ISO 13485 regulations, Medical Device manufacturing experience, Cleanroom manufacturing experience
• Experience with usage of common inspection tools (e.g., rulers, calipers): read blueprint drawings. Knowledge of computer software programs including Microsoft Word, & Excel.
• Experience with usage of inspection techniques and knowledge of statistical sampling plans. Strong attention to detail. Ability to balance and prioritize inspections and job responsibilities to support production. Focused with a strong sense of urgency
• Good verbal and written communication skills, ability to communication and interact well with all levels of personnel. Ability to work with a diverse group of people

PREFERRED QUALIFICATIONS

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

Education/Certifications:

• Technical College
• Associate’s Degree
• Bachelor’s Degree

Additional Experience, Skills, Knowledge and/or Abilities:

• ASQ Certifications such as but not limited to CQI or CQT

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 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 standing.
• This position requires frequent or continuous walking.
• 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 requires frequent or continuous bending, stooping, kneeling, or crouching.
• This position requires frequent or continuous exposure to dust, fumes, gases, odors or other airborne irritants.
• 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 $26.36 to $33.00 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.

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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