HFN: QA​/QC Engineer II

Job Title

HFN: QA/QC Engineer II

Job :

Location:

US-AZ-Phoenix (Location-Specific Position)

Job Type: Full-Time

With a mantra of Empowering Human Potential, Hanger, Inc. is the world s premier provider of orthotic and prosthetic (O&P) services and products, offering advanced O&P solutions, clinically differentiated programs and customer service. Hanger s Patient Care and Products & Services segments cover clinics, devices, products and rehabilitative solutions. The company aims to lead the orthotic and prosthetic markets by providing superior patient care and outcomes.

• Coordinate and perform quality assurance and product development activities in compliance with medical device regulations (21 CFR 820, ISO 13485:2016, ISO 14971, MDD as applicable).
• Manage incoming inspection and product release activities; ensure incoming and final release products meet specifications and QA requirements.
• Oversee document control, CAPA activities, and product review investigations; work with Product Development to ensure design control is followed for new and existing product lines.
• Perform QA/QC activities during design, manufacturing, and product fulfillment processes in accordance with 21 CFR 820, ISO 13485:2016, and CE requirements.
• Act as complaint management coordinator; process all complaints related to ININC products in a uniform and timely manner according to applicable regulations.
• Maintain and monitor product traceability data from receiving through final destination.
• Perform validation activities including IQ, OQ, and PQ per 21 CFR 820 and 21 CFR Part 11.
• Manage calibration programs and track equipment maintenance to ensure timely calibration and validation of measuring and critical operational equipment.

• Bachelor s degree in Biochemical, Chemical Engineering or related field
• Minimum of 2 years of related experience

• MS in engineering is preferred
• 3 years of medical device industry experience, with at least 2 years in quality and regulatory affairs
• Experience in manufacturing medical devices with electronic components
• Broad understanding of 21 CFR 820, 21 CFR Part 11, ISO 13485:2003 (or 2016), and international regulatory requirements
• Experience leading CAPA programs to ensure compliance with defined quality systems
• Experience scheduling internal audits and developing SOPs and Work Instructions
• Experience as main company representative during audits to FDA or ISO standards

• Ability to work with internal and external stakeholders
• Multitasking with deadlines
• Strong independent work capabilities on time-sensitive projects
• Strong written and oral communication skills
• Knowledge of medical device development and commercialization
• Understanding of electronic assembly and component manufacturing processes
• Integrity, honesty, transparency, and respect in all relationships
• Patient-focused mindset and dedication to quality outcomes
• Collaborative and constructive communication
• Continuous innovation and adaptability to change
• Focus on superior outcomes and process calibration

• Competitive compensation packages
• 8 paid national holidays and 4 floating holidays
• PTO, vacation and sick time
• Medical, dental, and vision benefits
• 401k retirement plan
• Paid parental bonding leave
• Flexible work schedules and part-time opportunities
• Employee referral bonus program
• Mentorship programs
• Student loan repayment assistance by location
• Relocation assistance
• Travel opportunities for certain roles

EEO Statement: Hanger, Inc. is an equal opportunity employer. All conditions and privileges of employment are administered to all employees without discrimination or harassment due to protected characteristics. Retaliation against anyone for reporting discrimination or harassment is prohibited.

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