Hanger, Inc.

QA/QC Engineer II

Hanger, Inc.

full-time

Posted on:

Location Type: Office

Location: Phoenix • Arizona • United States

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About the role

  • Implement QA/QC activities according to the requirements of 21 CFR 820, ISO 12345:2003, and CE mark during design, manufacturing, and product fulfillment process.
  • Perform incoming inspections, final product release inspections, and preliminary product failure investigation/testing as a part of CAPA process.
  • Act as complaint management coordinator to receive and process all complaints related to ININC products.
  • Manage document control activities according to the FDA and international regulations.
  • Manage quality records including device history records, QA records, test reports, manufacturing records, and equipment records.
  • Maintain and monitor product traceability data from receiving through the final destination.
  • Perform validation activities including IQ, OQ, and PQ processes according to 21 CFR 820 and 21 CFR Part 11.
  • Manage calibration programs and track equipment maintenance.

Requirements

  • Minimum: Bachelor’s degree in electrical or mechanical engineering
  • Minimum of 2 years of related experience
  • Preferred MS in electrical or mechanical engineering is preferred.
  • 3 years of experience in medical device industry, of which 2 years should be quality and regulatory affairs.
  • Experience in manufacturing of medical device with electronic components is preferred.
  • Broad understanding of 21 CFR 820, 21 CFR Part 11, ISO 13485:2003, and international regulatory requirements.
  • Managing and leading CAPA program to be compliant to a defined quality system.
  • Experience scheduling, managing internal audits and developing SOPs and Work Instructions.
  • Experience as main company representative to be audited to FDA or ISO standards.
Benefits
  • 8 Paid National Holidays & 4 additional Floating Holidays
  • PTO that includes Vacation and Sick time
  • Medical, Dental, and Vision Benefits
  • 401k Savings and Retirement Plan
  • Paid Parental Bonding Leave for New Parents
  • Flexible Work Schedules and Part-time Opportunities
  • Generous Employee Referral Bonus Program
  • Mentorship Programs- Mentor and Mentee
  • Student Loan Repayment Assistance by Location
  • Relocation Assistance
  • Regional & National traveling CPO/CO/CP opportunities
  • Volunteering for Local and National events such as Hanger’s BAKA Bootcamp and EmpowerFest
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
QA/QC activitiesincoming inspectionsfinal product release inspectionspreliminary product failure investigationCAPA processdocument controlvalidation activitiesIQ processesOQ processesPQ processes
Soft Skills
complaint managementmanagementleadershipschedulinginternal auditsdevelopment of SOPsdevelopment of Work Instructions
Certifications
Bachelor’s degree in electrical engineeringBachelor’s degree in mechanical engineeringMS in electrical engineeringMS in mechanical engineering