Quality Systems Manager

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.

The Quality Systems Manager is part of Hanger’s Supply Chain & Customer Operations Business Process & Transformation Team.  The role is responsible for developing and overseeing Hanger Supply Chain and Customer Operations’ Quality Management System (QMS), developing Standard Operating Procedures, incorporating key performance metrics, and recommending improvement.  This role is responsible for developing collaborative relationships with functional leaders to identify and champion continuous improvement efforts, support employee training on QMS and establish effective comprehensive data collection for analytics and reporting.

• Develop and maintain quality system-related procedures including as they are anticipated to evolve; support continuous improvement efforts.
• Coordinate and lead QMS audits, plans for Corrective and Preventive Actions (CAPA) related to internal QMS audit findings, and remediate gaps identified in the QMS.
• Work collaboratively and liaise with cross-functional stakeholders to design, implement, improve and document procedures for change management, process control, CAPA, process improvement, and document control.
• Spearhead evaluation & validation of various quality-related systems.
• Maintain and manage the risk management analysis (and other supporting documentation) needed to manage change requirements.
• Support engineering & development efforts to ensure compliance to procedures and regulatory requirements.
• Implement new or enhanced policies, standards and practices regarding quality as required by regulatory agencies.
• Prepare management reports from quality data, including incoming material and overall quality system performance; provide insight and recommendations for improvement.
• Prepare and act as lead presenter for Management Review meetings to review the effectiveness of the QMS.

Required

• BA/BS degree and 8+ years’ direct experience in quality initiatives, training programs and implementing process improvements OR 12 years direct experience in lieu of bachelor’s degree.

Preferred

• BA/BS Degree in Supply Chain Management or equivalent.
• Quality Management Certification.
• Project Management / Six Sigma Certification / Green Belt – Black Belt certification/training.
• Experience working in multiple manufacturing facility environments.
• Experience in Power BI or similar digital systems.
• Experience in FDA regulations within manufacturing.

• Extensive knowledge of quality procedures and programs.
• Knowledge of FDA Regulations in manufacturing compliance.
• Proven track record of change management.
• Demonstrated balance of strategic vision and execution skills.
• Proven skills working with corporate functions and business units.
• Project management experience and proven track record of achieving objectives on time.
• Proficient in various software products, such as, Word, Excel, PowerPoint, and Power BI.
• Highly organized, process oriented, with strong communication skills.
• 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.

• 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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