Quality Engineer

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.

The Quality Engineer develops, evaluates, revises, and applies the Quality System and Quality Assurance practices and needs of the company's product line including raw materials, fabrication equipment, and finished products.

Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations including the preparation, creation, and maintenance of regulatory documentation in support of submissions, g. FDA 510(k) applications, technical files, and quality system documentation guided by CE, ISO and FDA compliance.
• Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary.
• Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed.
• May assure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations.
• Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.
• Maintains product documentation and technical support material in accordance with design controls.
• Collaborates with the engineering team to manage product documentation.
• Prepares & submits post market reports and other required documentation.
• Liaison with outside authorized representatives.
• Create an environment which is consistent with the company's values and objectives.
• General training and education of technical staff in Quality System and regulatory compliance.
• Perform other duties or special projects as assigned.

• BS Degree in Industrial Engineering, Mechanical Engineering, Quality Engineering, and/or Regulatory Affairs Engineering
• Additional degrees and/or coursework in legal science, intellectual property, regulatory affairs, and/or quality assurance is an asset
• Minimum two years of manufacturing engineering or quality engineering experience and quality management systems
• Relevant medical device regulatory experience
• Regulatory (FDA, CE, MDR(EU)) experience
• Experience writing technical product documentation (handbooks, guides, website copy, etc.)
• Project management experience

• Strong interpersonal, oral and written communication skills.
• Strong analytical and process focus skills.
• Required to be proficient in Windows Based office technologies (ex. Word, Excel, PowerPoint)
• 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.

Pay range of $93,400 -$116,500 + benefits. This pay range is posted to comply with Illinois Law. Hanger salary ranges vary based on skill, ability, knowledge, geographic location and other variables.

• 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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