Careers \ Quality Engineer

 

The Quality Engineer will work as a member of the Quality and Regulatory group to ensure compliance with FDA and international regulations and will participate in the ongoing improvement and management of SpineFrontier’s Quality Management System. The successful candidate will serve as the quality representative on product development teams, facilitate compliance efforts across the organization, oversee acceptance activities, participate in complaint handling, and implement corrective/preventive action. This role is also highly integrated with supply chain management to ensure appropriate qualifications, audits, and quality planning throughout the supply chain.

 

This is an opportunity for an experienced quality engineer to apply their knowledge and clearly see the benefits realized from their individual contribution.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  1. Manage the Engineering Change Order process
  2. Provide quality and possibly regulatory input to product development teams
  3. Lead risk management efforts for product development teams
  4. Instrumental in verification and/or validation activities
  5. Ensure compliance with design controls throughout product lifecycle
  6. Manage incoming, in process, and final acceptance activities
  7. Conduct internal and supplier quality system audits
  8. Conduct investigations and documenting assigned complaints
  9. Facilitate corrective and preventive actions throughout the organization
  10. Participate in Material Review Board and Design Reviews
  11. Work with internal teams and vendors to resolve disposition of Non-Conforming Material

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, or to train technically-competent individuals in company specific software.

 

EDUCATION AND/OR EXPERIENCE

• 1 to 3+ years in quality (required) or regulatory (desirable) role in medical devices
• B.S. in engineering (preferred) or science
• Strong knowledge of the 21CFR 820 QSR, ISO 13485:2003, MDD, and global harmonization
• Quality auditing experience (preferred: in lead role)
• Successful history serving as quality representative on product development teams
• Ability to work in an extremely fast paced and dynamic environment.
• Proficient in Microsoft Office Pro; Adobe, CAD (highly desirable)
• Legally authorized to work in the United States on a regular full-time basis without restrictions

TRAVEL

• 10%

*We offer tremendous room for advancement and income potential.
All submissions will be held in the strictest confidence. This position is being sought after for immediate hire.

SpineFrontier is an Equal Opportunity Employer.

 

Please submit your resume and cover letter to mycareer@spinefrontier.com

 

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