Sr. Supervisor, Quality Assurance

Hanger, Inc.; Chicago (IL); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Benefits

401k Savings and Retirement Plan

Paid Parental Leave

Job summary

Hanger, Inc. is seeking a Senior Supervisor, Quality Assurance to lead a QA team focused on ensuring regulatory and customer compliance across product lines.

You will drive investigations, CAPA programs, and documentation controls while coordinating with cross‑functional teams to sustain high quality standards. Responsibilities include managing audits, reviewing test records, and guiding corrective actions.

Qualifications

• Bachelor’s degree in engineering preferred.
• Five years’ experience in a leadership role in quality of a related environment or deep technical experience with Coapt technology paired with a penchant for documentation, communication, and organization.
• Strong knowledge of ISO 13485, FDA, and QMS requirements in a medical device function.
• Strong knowledge of inspection methods, sampling plans, measurement tools, and testing techniques.
• Expertise in root‑cause analysis methodologies.
• Familiarity with production workflows, engineering change management, and document control processes.
• Knowledge of internal and external audit practices and requirements.
• Understanding of validation principles, risk management, and process control.

Responsibilities

• Provide day‑to‑day leadership, coaching, and performance management for the QA team, ensuring efficient workflow, adherence to standards, and continuous skill development.
• Oversee quality inspection, testing, and documentation processes to ensure products meet regulatory, customer, and company standards.
• Lead complex nonconformance investigations, perform root‑cause analysis, and drive corrective and preventive actions that eliminate systemic issues.
• Review, approve, and maintain quality documentation such as inspection records, test results, deviations, change controls, and product release decisions.
• Coordinate and support internal audits, customer audits, and regulatory inspections; ensure prompt and accurate responses to findings.
• Analyze quality performance metrics and trends, presenting insights and actionable recommendations to leadership.
• Partner with Operations, Engineering, Supply Chain, and production leadership to resolve quality issues and improve manufacturing processes.
• Ensure the proper implementation and maintenance of quality system requirements (ISO, FDA, or industry‑specific standards).
• Lead or support validation activities, including equipment qualification, process validation, and documentation updates.
• Promote a culture of quality, accountability, and continuous improvement across the organization.
• Support strategic initiatives related to quality planning, staffing needs, system improvements, and cross‑functional project execution.
• Identify trends in scrap, rework, and process deviations; recommend improvements to enhance quality and efficiency.
• Support internal audits and contribute to maintaining compliance with ISO 13485, FDA, and QMS requirements.
• In partnership with manager, develop or update inspection plans, work instructions, and standard operating procedures.

Skills

Leadership

Quality Assurance

Root cause analysis

Documentation

Audit readiness

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Job description

Why Us?

Coapt provides transformative technologies that improve quality of life for upper-limb prosthesis users. Based in industry-leading research in bionics and clinically-dedicated engineering, its cutting‑edge technology gives prosthesis users more intuitive, natural and personal control to fit their lifestyles. Now a Hanger, Inc. company, Coapt continues to lead in innovation and excellence in the field.

Why Us?

Coapt provides transformative technologies that improve quality of life for upper-limb prosthesis users. Based in industry-leading research in bionics and clinically-dedicated engineering, its cutting‑edge technology gives prosthesis users more intuitive, natural and personal control to fit their lifestyles. Now a Hanger, Inc. company, Coapt continues to lead in innovation and excellence in the field.

Could This Be For You?

The Senior Supervisor, Quality Assurance provides leadership and oversight to a Quality Assurance team for Fillauer Coapt, Point Designs, or another Hanger Products & Services entity, ensuring products and processes meet regulatory, customer, and organizational standards. This role develops and maintains quality system policies, procedures, and systems compliant with the regulatory requirements of the entity’s product lines, manages quality operations, leads root‑cause investigations, drives continuous improvement initiatives, and supports compliance with internal and external audit requirements.

Your Impact

• Provide day‑to‑day leadership, coaching, and performance management for the QA team, ensuring efficient workflow, adherence to standards, and continuous skill development.
• Oversee quality inspection, testing, and documentation processes to ensure products meet regulatory, customer, and company standards.
• Lead complex nonconformance investigations, perform root‑cause analysis, and drive corrective and preventive actions that eliminate systemic issues.
• Review, approve, and maintain quality documentation such as inspection records, test results, deviations, change controls, and product release decisions.
• Coordinate and support internal audits, customer audits, and regulatory inspections; ensure prompt and accurate responses to findings.
• Analyze quality performance metrics and trends, presenting insights and actionable recommendations to leadership.
• Partner with Operations, Engineering, Supply Chain, and production leadership to resolve quality issues and improve manufacturing processes.
• Ensure the proper implementation and maintenance of quality system requirements (ISO, FDA, or industry‑specific standards).
• Lead or support validation activities, including equipment qualification, process validation, and documentation updates.
• Promote a culture of quality, accountability, and continuous improvement across the organization.
• Support strategic initiatives related to quality planning, staffing needs, system improvements, and cross‑functional project execution.
• Identify trends in scrap, rework, and process deviations; recommend improvements to enhance quality and efficiency.
• Support internal audits and contribute to maintaining compliance with ISO 13485, FDA, and QMS requirements.
• In partnership with manager, develop or update inspection plans, work instructions, and standard operating procedures.

Minimum Qualifications

• Bachelor’s degree in engineering preferred.
• A minimum of five years’ experience in a leadership role in quality of a related environment or deep technical experience with Coapt technology paired with a penchant for documentation, communication, and organization.
• Strong knowledge of ISO 13485, FDA, and QMS requirements in a medical device function.
• Strong knowledge of inspection methods, sampling plans, measurement tools, and testing techniques.
• Expertise in root‑cause analysis methodologies.
• Familiarity with production workflows, engineering change management, and document control processes.
• Knowledge of internal and external audit practices and requirements.
• Understanding of validation principles, risk management, and process control.

Additional Success Factors

• Ability to interpret technical drawings, specifications, and process instructions.
• Skilled in quality data analysis, statistical techniques, and reporting to identify trends and opportunities.
• Strong understanding of defect containment, corrective action development, and continuous improvement strategies.
• Demonstrated ability to supervise, motivate, and develop team members, including coaching for performance and growth.
• Skilled in delegation, prioritization, and managing multiple simultaneous tasks under deadlines.
• Ability to lead cross‑functional teams and drive consensus in complex problem‑solving situations.
• Excellent verbal and written communication, including the ability to simplify complex information.
• Strong partnership skills with Operations, Engineering, and leadership stakeholders.
• Ability to navigate difficult conversations with professionalism and clarity.
• Strong judgment in evaluating quality risks, making product disposition decisions, and implementing corrective actions.
• Ability to think strategically while also executing hands‑on problem‑solving.
• High attention to detail and strong organizational capabilities.
• Ability to work in fast‑paced environments with shifting priorities.
• Commitment to maintaining the highest standards of compliance, documentation accuracy, and product quality.
• Demonstrated initiative, ownership, and accountability for results.
• Directly supervises Quality personnel, including Quality Control and Quality Assurance Technicians.
• Provides mentorship, coaching, and daily guidance to team across quality.
• Evaluates employee performance using KPIs, conducts reviews, and identifies training needs to ensure competency and efficiency.
• Enforces safety, quality, and continuous improvement standards, holding teams accountable for compliance and operational discipline.
• Oversees workflow scheduling, task assignments, and resource allocation, ensuring proper staffing and equipment utilization.
• Receives general direction from senior leadership who sets production goals, safety expectations, and organizational priorities.
• Collaborates with cross functional leaders (engineering, procurement, quality, logistics) who also influence production priorities, resource planning, and workflow alignment.

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

Pay range of $90,000-$100,000/year + bonus+ benefits. This pay range is posted to comply with State Law. Hanger salary ranges vary based on skill, ability, knowledge, geographic location and other variables.

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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