Quality Control Inspector

Summary Statement

For more than a century Ottobock has pursued the mission of helping people living with limb loss or mobility challenges regain or maintain their freedom of movement. We do this through the development of leading prosthetic, orthotic and wheelchair innovation and an unwavering commitment to delivering superior patient care experiences. As a growing healthcare company, we continue to invest in both our people and new service offerings. With more than 8,000 employees worldwide and 1,100 across North America, we are dedicated to advancing the O&P industry and improving the lives of the people served by it.

This role is temp to hire.

Position Summary

The Quality Technician is responsible for ensuring compliant processing of Device History Records (DHRs) and final product release. This role includes inspecting incoming components to meet specification requirements and maintaining the calibration of measurement devices. The Quality Technician supports the Quality Team in upholding and improving Quality Systems in compliance with FDA 21 CFR Part 820 and ISO 13485:2016 standards, contributing to overall product quality and regulatory compliance

Duties & Responsibilities

• Review Device History Records and documentation to meet FDA and ISO quality standards.
• Inspect components and documentation to ensure compliance with regulatory requirements.
• Conduct incoming inspections of components, verifying critical dimensions against specifications.
• Use measurement instruments accurately and ensure proper calibration of tools and equipment.
• Maintain precise and complete records of inspections and quality findings.
• Identify and track any nonconformities found in products or processes.
• Coordinate timely equipment calibration and verification with relevant teams.
• Partner with production teams to promote understanding of quality documentation and practices.
• Support continuous improvement of the Quality System with the Quality Team.
• Maintain a clean, safe work environment and provide guidance to others as needed.
• Perform other duties as assigned.

Qualifications

• High School Diploma (or GED) required.
• Strong attention to detail.
• Good communication skills. • Ability to read and write English fluently.
• Experience in Medical Device industry preferred.
• Experience in QA/QC function preferred.
• Knowledge of FDA regulations and ISO standards preferred.
• GD&T fundamentals experience preferred.

Benefits

• Medical
• Vision
• Dental
• Health savings accounts with employer contribution
• Flexible spending account options
• Company-paid life insurance policy
• Paid time off
• Company holidays
• Floating holidays
• 100% company-paid short & long-term disability
• 401k match up to 3.5%
• Paid parental leave
   

  Ottobock will not discriminate against any applicant for employment because of race, color, age, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age (40 or older), disability or genetic information. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age (40 or older) disability and genetic information.
   

  Note: Ottobock does not accept CVs from recruiting agencies or staffing firms and will not consider payment of any referral compensation or recruiter fee relating to unsolicited CVs. We kindly request that all job seekers interested in opportunities with us apply directly through our official careers page: https://www.ottobock.com/en-us/careers