Quality Systems Manager
4 weeks ago
Hanger, Inc. is seeking a highly skilled Quality Systems Manager to join its Supply Chain & Customer Operations Business Process & Transformation Team. The successful candidate will be 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.
Key Responsibilities- Develop and maintain quality system-related procedures, including those related to 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 and validation of various quality-related systems.
- Maintain and manage the risk management analysis (and other supporting documentation) needed to manage change requirements.
- Support engineering and 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.
- 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.
- 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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