QA/QC Engineer I

Hanger, Inc. • Phoenix, AZ

3d

About The Position

The Quality Assurance Engineer I supports quality assurance and product development activities in accordance with medical device regulations, including 21 CFR 820, the Medical Device Directive (MDD), ISO 13485, and ISO 14971. Under the guidance of senior QA staff, the engineer assists with incoming inspection and product release tasks by following established procedures to help ensure products meet defined specifications and quality requirements. The duties will also include providing support for document control activities, helping maintain quality records, assisting with CAPA documentation, and participating in basic product review investigations as assigned. The QA Engineer I also works with Product Development by completing required design control documentation and following established processes for new and existing product lines.

Requirements

• Bachelor’s degree in electrical or mechanical engineering

Nice To Haves

• Some experience in the medical device industry, quality assurance, regulatory affairs, or a related engineering environment; exposure to products with electronic components is preferred.
• Familiarity with basic quality and regulatory concepts such as 21 CFR 820, 21 CFR Part 11, and ISO 13485; coursework, project work, or prior internship experience in these areas is preferred.
• Experience supporting CAPA‑related activities (e.g., gathering data, documenting actions, assisting with investigations) within a structured quality system is beneficial.
• Ability to work and interact with internal and external parties including internal customers, distributors, suppliers.
• Ability to work in multi-tasked environment with deadlines.
• Strong ability to work independently on multiple time sensitive projects.
• Strong written and oral communication skills.
• Basic knowledge of medical device development and commercialization
• Understanding of electronic assembly and component manufacturing processes.
• Act with integrity in all ways and at all times, remaining honest, transparent, and respectful in all relationships.
• Keep the patient at the center of everything that you do, building lifelong trust.
• Foster open collaboration and constructive dialogue with everyone around you.
• Continuously innovate new solutions, influencing and responding to change.
• Focus on superior outcomes, and calibrate work processes for outstanding results.

Responsibilities

• Support QA/QC activities by following established procedures and requirements related to 21 CFR 820, ISO standards, and CE mark guidelines under the direction of senior team members.
• Perform basic incoming inspections and final product checks using predefined inspection criteria and document results accurately.
• Assist with complaint intake activities by logging complaints, organizing required documentation, and escalating issues to senior QA staff for evaluation in accordance with regulatory procedures.
• Provide support for document control tasks, including updating logs, routing documents for approval, and maintaining organized and compliant document files.
• Help maintain quality records, such as device history records, QA logs, test reports, and equipment records, ensuring files are complete and properly stored.
• Assist in tracking product traceability data by entering information into tracking systems and verifying completeness.
• Participate in validation activities (IQ, OQ, PQ) by collecting data, preparing documentation, and performing routine test steps under supervision.
• Support calibration and equipment maintenance programs by scheduling calibration service, maintaining calibration logs, and helping track equipment status.

Benefits

• Competitive Compensation Packages
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level