Staff Quality Engineer

Looking for a career where your work truly matters? At VB Spine, youll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. Were looking for a Staff Quality Engineer who can thrive in a fast-paced environment, lead complex quality initiatives, and support high-impact programs that drive product excellence and patient safety.

What Youll Do:

Work closely with operations and business functions to ensure product and process quality performance

Serve as the Quality representative on cross-functional teams to resolve key quality issues

Lead quality initiatives that support compliance to standards and drive process improvements

Develop, maintain, and improve internal procedures, SOPs, and work instructions

Assess internal and supplier change management activities

Apply risk management practices to manufacturing operations

Lead internal and supplier non-conformances and ensure timely closure

Lead CAPA projects, including investigation, implementation, and closure

Act as SME during audits by regulatory agencies, notified bodies, and other authorities

Lead process and quality system projects of moderate scope and complexity

Disposition non-conforming product within the MRB

Maintain KPIs, perform analyses, and interpret trends to drive action

Identify and execute supplier part certification opportunities

Support creation and maintenance of inspection methods and sampling plans

Perform supplier control activities, including on?site and desktop audits

Manage and maintain the Approved Supplier List (ASL)

Lead development and improvement of manufacturing processes

Lead supplier part approval activities for new products and changes

Apply foundational knowledge of manufacturing processes (milling, turning, heat treatment, passivation/cleaning)

Execute internal quality deliverables for engineering changes, product transfers, and supplier-initiated changes

Lead complex product transfers between manufacturing sites

Lead containment and communication activities related to potential product escapes

Lead execution and analysis of manufacturing-related complaints and field actions

Review, execute, and approve equipment, process, MSA, and software validation protocols/reports

Collaborate with Regulatory on creation and revision of IFUs

Review and approve quality records

Utilize ERP systems for purchasing and manufacturing quality processes

Promote Human Factors practices, including identification and mitigation strategies

Apply statistical analysis and process control methods for CAPA, management review, and QMS processes

Provide training (GMP, onboarding, etc.) and cross-functional support for NPD and process changes

Provide subject matter expertise and mentorship to junior Quality team members

What You Bring:

Bachelors degree required; Engineering discipline preferred (Biomedical, Process, Mechanical)

Minimum 5 years experience in a quality role within a medical device company (or equivalent regulated manufacturing experience)

Professional quality certification (MS, CQE, CRE, Six Sigma) highly desirable

Knowledge of quality concepts (Risk Management, CAPA, Audits, Statistics)

Knowledge of regulatory requirements (ISO 13485, FDA QSR, EU MDR)

Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.)

Strong investigation and root?cause analysis skills preferred

Process improvement and auditing skills preferred

Ability to read engineering drawings/technical specifications preferred

Ability to multitask, work independently, and participate in cross-functional teams

Project management skills and ability to influence without authority

Excellent communication, analytical, problem-solving, and technical writing skills

High attention to detail and strong organizational skills

Ability to meet physical requirements such as standing, walking, sitting, reaching, and standard vision capabilities

Why VB Spine?

We believe in growing talent from within. At VB Spine, youll join a high-performing team, benefit from peer and executive mentorship, and help shape strategy in the dynamic field of medical devicespositioning yourself to influence growth and innovation across the organization.

Compensation:

Pay for this role is competitive and based on experience, with additional factors like territory requirements, qualifications, and performance taken into account. The typical pay range for this position is $105,000 - 135,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined case?by?case and considers experience level, skillset, and market conditions.

Benefits include:

Comprehensive health, dental, and vision insurance

401(k) with company match

Paid time off (PTO) and holidays

Ongoing training and professional developmentOpportunity to grow within a fast-paced, dynamic company

We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self?identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labors Office of Federal Contract Compliance Programs (OFCCP) website at #J-18808-Ljbffr