This position requires an Engineering Degree and 1-3 years of the relevant industry experience. The Quality Engineer will work as a member of the Quality team 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.
Duties and responsibilities
- Manage the Engineering Change Order Process
- Provide quality and possibly regulatory input to product development teams
- Lead risk management efforts for the product development teams
- Manage verification and /or validation activities
- Ensure compliance with design controls throughout the product lifecycle
- Manage incoming, in process, and final acceptance activities
- Conduct internal and supplier quality system audits
- Conduct investigations and documenting assigned complaints
- Facilitate corrective and preventive actions throughout the organization
- Participate in Material Review Board and Design Reviews
- Own and manage Quality training assuring on-going compliance with regulations
- Work with internal teams and vendors to resolve disposition of Non-Conforming Material
To perform this job successfully, the candidate must be able to perform each essential duty satisfactorily; training will be provided as needed. 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.
- 1 to 3 + years in quality (required) or regulatory (desirable) role in medical devices
- B.S. in engineering (Medical or Biomedical preferred)
- Strong Knowledge of the 21CFR 820 QSR, ISO 13485:2003, MDD, and global harmonization
- Successful history serving as a 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
- 1-3 years of work experience
- 0-10% travel
- Experience in Orthopedic Medical Devices
- Quality auditing experience (preferred: in lead role)
Work is generally performed within an office environment, with standard office equipment available. Travel up to 10%.
Must be able to read, write and communicate fluently in English.