10 March, 2018
The Senior Quality Engineer is a member of the Quality team. They will work 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 work on major projects requiring in-depth knowledge and expertise.
The Senior Quality Engineer will manage junior members of the team, providing direction and mentorship while consistently demonstrating high levels of technical knowledge, ingenuity and creativity. This position requires collaboration with the Product Development team on design and development projects as wells as collaboration with supply chain to ensure appropriate qualifications, audits, and quality controls are implemented for SpineFrontier suppliers. 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 quality engineering (QE) team- Oversee incoming, in process and final acceptance activities- Work with internal teams and suppliers to resolve Non-Conforming Material Reports
– Manage corrective and preventive actions within the QE team
– Manage the calibrated equipment program
- Provide quality input to product development teams- Lead risk management efforts for product development teams (e.g. FMEA)
– Oversee verification and/or validation activities
– Ensure compliance with design controls throughout product lifecycle
– Participate in design reviews
- Conduct 1st party and 2nd party quality system audits- Participate in the Material Review Board (MRB)- Perform reliability analysis and develop risk based sampling plans
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.
Our Perfect Candidate
Education and Experience
- Bachelor’s Degree in Engineering (Medical or Biomedical preferred)
- 1-3+ years’ experience in quality (required) or regulatory (desirable) role in medical devices
- Strong Knowledge of the 21CFR 820 QSR, ISO 13485:2003, MDD, ISO 14971, and global harmonization
- Successful history serving as a quality representative on product development teams
- ASQ Certified Quality Engineer (CQE) preferred
- ASQ Certified Quality Auditor (CQA) preferred
- Legally authorized to work in the United States on a regular full-time basis without restrictions
- Experience in Orthopedic Medical Devices
- Quality auditing experience (preferred: in lead role)
Required Abilities and Skills
- Excellent verbal and written communications skills
- Ability to work in an extremely fast paced and dynamic environment
- Problem-solving and critical-thinking skills
- Proficiency in Microsoft Office Applications including Excel, PowerPoint, and Word
- Proficiency in Microsoft Office Pro; Adobe, AutoCAD, and SolidWorks
- Annual salary will commensurate with experience and education
- Comprehensive benefits package available including: Healthcare Insurance, Paid Vacation Holidays, 401k, Bonuses, Merit Increases, and Growth Opportunities
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.