Quality Engineer
About The Position
VB Spine is seeking a Quality Engineer to join their high-performing team. This role plays a meaningful part in ensuring the quality and safety of innovative spinal devices that improve patient lives. The Quality Engineer will serve as the Quality representative on cross-functional teams for new product development and changes to existing products or processes. They will execute quality initiatives to maintain compliance with standards and identify opportunities for process improvement. The role involves supporting the development, maintenance, and improvement of internal procedures, SOPs, and work instructions, as well as participating in risk management activities. The Quality Engineer will contribute to design reviews, support design verification and validation, and lead non-conformances, CAPA projects, and MRB dispositions. Additionally, they will support internal and external audits, perform supplier control activities, and assist with product transfers and engineering changes. Reviewing and approving validation protocols/reports and collaborating with Regulatory Affairs are also key responsibilities. The role requires monitoring quality KPIs, analyzing trends, and driving corrective actions, while applying statistical tools and advocating for Human Factors practices.
Requirements
- Bachelor’s degree in Engineering required (Biomedical, Mechanical, Process, or related engineering discipline strongly preferred)
- Knowledge of core Quality concepts including Risk Management, CAPA, Audits, and Statistics
- Strong problem-solving, analytical, and technical writing skills
- Excellent verbal, written, and interpersonal communication skills
- High attention to detail with strong organizational and multi-tasking abilities
- Ability to work independently and effectively within cross-functional teams
Nice To Haves
- Ability to read and interpret engineering drawings and technical specifications
Responsibilities
- Serve as the Quality representative on cross-functional teams for new product development and changes to existing products or processes
- Execute quality initiatives to maintain compliance with standards and identify opportunities for process improvement
- Support the development, maintenance, and improvement of internal procedures, SOPs, and work instructions
- Participate in risk management activities, including risk plans, risk reviews, and verification of risk controls
- Contribute to design reviews by identifying risks and ensuring design and manufacturing documentation adequately mitigates them
- Support design verification and validation activities, including statistical analysis and clear reporting with graphical support
- Lead and manage non-conformances (NCs), CAPA projects, and Material Review Board (MRB) dispositions with timely closure
- Support internal and external audits (regulatory agencies, notified bodies) and ensure timely resolution of findings
- Perform supplier control activities, including audits, supplier file management, and monitoring
- Support product transfers between sites and execution of engineering changes, holds, complaints, and field actions
- Review and approve validation protocols/reports for equipment, processes, MSA, and software
- Collaborate with Regulatory Affairs on Instructions for Use (IFUs) and review/approve quality records
- Monitor quality KPIs, analyze trends, and drive appropriate corrective actions
- Apply statistical tools and process control methods to support quality system processes
- Advocate for Human Factors practices and support training initiatives as needed
Benefits
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic company
- Potential for bonuses and incentives
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
