- Ensure the Quality Management System meets relevant quality standards.
- Support in QC inspection of devices.
- Collaborate on enhancing products, processes, and compliance.
- Contribute to creating and processing CAPAs and Nonconformance investigations.
- Handle customer complaint management.
- Participate in developing programs, processes, and work instructions.
- Deliver Quality-related training.
- Lead internal audits processes.
- Foster a positive organizational climate.
- Engage with other functional areas to drive quality improvement.
- 2-3 years of relevant experience
- Background in a manufacturing environment
- Experience with medical device manufacturing
- Knowledge in orthotics and prosthetics is a bonus
- Hands-on experience in audits and investigations
- Thorough understanding of quality regulations such as 21 CFR Part 820 and ISO 13485.
- Proficiency in quality tools and methodologies.
- Excellent attention to detail and analytical skills.
- Effective communication skills to convey complex quality concepts.
- Experience with quality management software and Microsoft Office.
- Strong organizational and time management skills.
- Ability to collaborate and engage with diverse stakeholders.
- Quality certifications are a plus.
- Competitive Compensation Packages
- Generous Paid Holidays & Flexible PTO
- Comprehensive Medical, Dental, and Vision Benefits
- 401k Savings and Retirement Plan
- Paid Parental Leave
- Flexible Work Options
- Employee Referral Bonus Program
- Mentorship Opportunities
- Student Loan Repayment Assistance
- Relocation Support
- National traveling opportunities
- Volunteering for Local and National events
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HFN-Quality Analyst - Phoenix, United States - Hanger Clinic
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Description
About the Company:
At Hanger, Inc., we are on a mission to boost Human Potential. As a global leader in orthotic and prosthetic (O&P) services, we provide top-notch O&P solutions, innovative programs, and exceptional customer support. With a rich history of 160 years of excellence, our vision at Hanger is to lead the orthotic and prosthetic markets by delivering outstanding patient care, results, services, and value.
Join Our Team:
Position Summary:
We are looking for a skilled quality analyst/technician to play a key role in maintaining and enhancing Quality Management System and improvement initiatives at our O&P fabrication sites.
Main Responsibilities:
Job Complexity:
You will tackle problems with a focused scope following standard practices and procedures to drive solutions. Building strong internal relationships is key.
Supervision:
You will receive detailed instructions for your tasks.
Full-time position at our office with some flexibility in hours.
Requirements:
Desired Qualifications:
Minimum: High school diploma or GED
Preferred: Associates or bachelor's degree in STEM or related field.
Additional Attributes for Success:
Perks of Joining Us:
Hanger, Inc. is an equal opportunity employer committed to fostering an inclusive workplace. We value diversity and do not tolerate any form of discrimination.