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Lead Quality Control Inspector

Orthofix
United States, Texas, Lewisville
3451 Plano Parkway (Show on map)
Jan 11, 2025

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.

How you'll make a difference?

The Lead Quality Control Inspector ensures that all parts received through the receiving and inspection process meet inspection specification standards per pertaining QOPs, WIs and inspection documentation requirements before product is released in to Finished Goods, supports Engineering and Product Development department with drawing/inspection techniques feedback.

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 and tasks as needed and assigned.

  • Under limited supervision maintains a high level of inspection and productivity, perform inspection of manufactured parts, subassemblies, gauges, raw material, etc. Complete first article inspection of new and revised parts.

  • Identifies and issues non-conforming product reports for product and raw material that do not meet specifications.

  • Accurately complete all quality inspection related documentation assuring GDP (Good Documentation Practices) are being follow throughout the inspection process.

  • Supports Engineering and Product Development as needed with input on new drawings/RIRs call outs for Alpha Beta products.

  • Conduct final inspection of finished products.

  • Train inspectors as necessary for usage of inspection equipment and measuring techniques.

  • Assists with revisions of procedures and work instructions, inspection forms and other quality related document as needed.

  • Assist Quality Engineering in the development of new inspection methods to improve accuracy and reduce inspection lead time.

  • Serves as the technical knowledge resource for others as needed.

  • Other duties as requested by the Quality Control Supervisor.

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:

  • A minimum of 10 years' experience as a mechanical Quality Control Inspector

  • 5 years Quality Control Inspector in the medical device industry

  • Must have demonstrated ability to use calipers, micrometers, optical comparator, pin/depth/hex gauges, scales, vision system and other standard mechanical inspection tools.

  • Must be able to read, analyze and interpret blueprints, GD&T, work instructions, engineering specifications and inspection documents, experience with writing non-conformance reports

  • Able to perform detailed dimensional and cosmetic inspection on products,

  • Must be able to communicate technical information, both verbal and written,

  • Demonstrated ability to use shop math techniques (addition, subtraction, multiplication, division of decimals and fractions),

  • Ability to use standard computer software i.e. Word, Excel, Outlook,

  • Must be able to speak, read and write English fluently

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:

  • ASQ Certification preferred

Additional Experience, Skills, Knowledge and/or Abilities:

  • Technical background in Medical Device industry is desirable

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.

  • No additional physical requirements or essential functions for this position.

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.

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