Quality Control Technician III; 2nd Shift

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