Quality Engineer
VB Spine · Allendale, NJ · Yesterday
Quality Assurance$80k–$95k/yrFull-time
What You’ll Do
- 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
- Lead and manage non-conformances (NCs), CAPA projects, and Material Review Board (MRB) dispositions with timely closure
- Support 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
What You Bring
- 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
- Ability to read and interpret engineering drawings and technical specifications (preferred)
- 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
- Willingness to travel up to 25% as needed
Why VB Spine?
- We believe in growing talent from within.
- Join a high-performing team, benefit from peer and executive mentorship, and play a meaningful role in ensuring the quality and safety of innovative spinal devices that improve patient lives.
- Compensation is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $80,000.00 - $95,000.00 annually, with potential for bonuses and incentives plus benefits.
- Benefits include Comprehensive health, dental, and vision insurance, 401(k) with company match, Paid time off (PTO) and holidays, Ongoing training and professional development opportunities, and Opportunity to grow within a fast-paced, dynamic company.