HFN: QA/QC Engineer II

Why Us?

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 the most advanced O&P solutions, clinically differentiated programs and unsurpassed customer service. Hanger's Patient Care segment is the largest owner and operator of O&P patient care clinics nationwide. Through its Products & Services segment, Hanger distributes branded and private label O&P devices, products and components, and provides rehabilitative solutions to the broader market. With 160 years of clinical excellence and innovation, Hanger's vision is to lead the orthotic and prosthetic markets by providing superior patient care, outcomes, services and value. Collectively, Hanger employees touch thousands of lives each day, helping people achieve new levels of mobility and freedom.

Could This Be For You?

The Quality Assurance Engineer has the responsibilities to coordinate and perform quality assurance and product development activities according to medical device regulations of 21 CFR 820 and/or ISO 13485:2016, Medical Device Directive (MDD), ISO 13485, and ISO 14971. 

QA Engineer will be responsible for managing incoming inspection and product release activities.  This includes ensuring incoming and final release products meet specifications and QA requirements. The duties will also include document control management, management of CAPA activities, product review investigations. QA Engineer will work with Product Development to ensure that design control process is followed for new and existing product lines.  

Your Impact

• Implement QA/QC activities according to the requirements of 21 CFR 820, ISO 13485:2016, 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. This includes ensuring that all complaints are processed in a uniform and timely manner according to 21 CFR 820, MDD, and ISO 13485:2016 regulations.
• Manage document control activities according to the FDA and international regulations. This includes ensuring that all document changes are processed and approved according to the standard operating procedures.
• 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 to ensure that measuring and critical operational equipment is timely calibrated and validated.

Minimum Qualifications

Minimum:

• Bachelor’s degree in Biochemical, Chemical engineering
• Minimum of 2 years of related experience

Preferred

• MS in 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

Additional Success Factors

• 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.
• 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.

Our Investment in You

• 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

Hanger, Inc. is committed to providing equal employment opportunity in all aspects of the employer-employee relationship. All conditions and privileges of employment are administered to all employees without discrimination or harassment because of race, religious creed, color, age, sex, sexual orientation, gender identity, national origin, religion, marital status, medical condition, physical or mental disability, military service, pregnancy, childbirth and related medical conditions, special disabled veteran status, or any other classification protected by federal, state, and local laws and ordinances. The company will comply with all applicable state or local fair employment laws that forbid discrimination or harassment on the basis of other protected characteristics. Retaliation against any employee for filing or supporting a complaint of discrimination or harassment is prohibited.

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