Valid8 Financial, Inc.
Overview
Location : Leesburg, VA (hybrid) 25% travel
Company : VB Spine Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re seeking a detail-oriented, driven Senior Quality Engineer to provide leadership in quality assurance, control, and preventive activities. In this role, you’ll manage quality activities for internal and external suppliers, support process development, verification, validation, and product transfer, and ensure compliance with medical device regulations and industry standards.
What You’ll Do
Partner with Operations and other business functions to ensure quality performance of products and processes.
Serve as the Quality representative on cross-functional teams to address key quality issues.
Support compliance to evolving standards and regulatory changes through the development and improvement of SOPs, work instructions, and procedures.
Evaluate and manage internal and supplier change management activities.
Apply risk management principles to manufacturing operations.
Lead internal and supplier-driven non-conformances, CAPA investigations, and timely closures.
Act as subject matter expert during internal and external audits, including front and backroom support.
Disposition non-conforming product within the Material Review Board (MRB).
Monitor and analyze KPIs to drive corrective actions and quality improvements.
Collaborate with stakeholders to certify supplier parts and develop inspection methods.
Conduct supplier control activities including audits, supplier file maintenance, and Approved Supplier List (ASL) updates.
Support manufacturing process development and improvement efforts.
Lead part approval activities for new products and changes.
Execute quality deliverables for engineering changes, product transfers, and supplier-initiated changes.
Lead containment activities for potential product escapes.
Support manufacturing-related complaints and product field actions.
Review, execute, and approve validation protocols and reports for equipment, processes, MSA, and software.
Collaborate with Regulatory to develop and revise Instructions for Use (IFUs).
Review and approve quality records.
Apply statistical analysis and process control methods to support CAPAs and management reviews.
Provide GMP training, onboarding, and other quality-related training as needed.
Support new product development and changes to existing products and processes.
What You Bring
Bachelor’s degree required; Engineering discipline preferred (Biomedical, Process, or Mechanical Engineering recommended).
Minimum 3 years’ experience in a quality role within a medical device company (or equivalent regulated manufacturing experience).
Professional certification in a quality discipline (e.g., Lead Auditor, CQE, CRE, Six Sigma) highly desirable.
Knowledge of quality concepts such as Risk Management, CAPA, Audits, and Statistics.
Understanding of applicable regulations (ISO 13485, FDA QSR, EU MDR) desired.
Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
Skills in formal investigation, root cause analysis, and process improvement preferred.
Process-based auditing experience preferred.
Ability to interpret engineering drawings and technical specifications.
Strong project management skills and the ability to influence without authority.
Why VB Spine? We believe in growing talent from within. At VB Spine, you’ll join a high-performing team, benefit from mentorship at all levels, and play a key role in advancing innovation in spinal care. Your work will have a direct impact on patient safety and surgical success.
Compensation Pay for this role is competitive and based on experience. Final compensation is determined on a case-by-case basis, considering skills, experience, and market conditions.
Benefits
Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunities to grow within a fast-paced, dynamic company
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What is the highest level of education you’ve obtained?
This role requires a HYBRID work schedule in which you need to be in the office 2-4 times a week depending on the needs of the business. Are you able to meet those requirements?
How did you hear about this position?
If you were referred, please list the name of the referring employee.
Do you have a non-compete that could impact your ability to work for VB Spine?
We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans\' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA.
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 Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.
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Location : Leesburg, VA (hybrid) 25% travel
Company : VB Spine Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re seeking a detail-oriented, driven Senior Quality Engineer to provide leadership in quality assurance, control, and preventive activities. In this role, you’ll manage quality activities for internal and external suppliers, support process development, verification, validation, and product transfer, and ensure compliance with medical device regulations and industry standards.
What You’ll Do
Partner with Operations and other business functions to ensure quality performance of products and processes.
Serve as the Quality representative on cross-functional teams to address key quality issues.
Support compliance to evolving standards and regulatory changes through the development and improvement of SOPs, work instructions, and procedures.
Evaluate and manage internal and supplier change management activities.
Apply risk management principles to manufacturing operations.
Lead internal and supplier-driven non-conformances, CAPA investigations, and timely closures.
Act as subject matter expert during internal and external audits, including front and backroom support.
Disposition non-conforming product within the Material Review Board (MRB).
Monitor and analyze KPIs to drive corrective actions and quality improvements.
Collaborate with stakeholders to certify supplier parts and develop inspection methods.
Conduct supplier control activities including audits, supplier file maintenance, and Approved Supplier List (ASL) updates.
Support manufacturing process development and improvement efforts.
Lead part approval activities for new products and changes.
Execute quality deliverables for engineering changes, product transfers, and supplier-initiated changes.
Lead containment activities for potential product escapes.
Support manufacturing-related complaints and product field actions.
Review, execute, and approve validation protocols and reports for equipment, processes, MSA, and software.
Collaborate with Regulatory to develop and revise Instructions for Use (IFUs).
Review and approve quality records.
Apply statistical analysis and process control methods to support CAPAs and management reviews.
Provide GMP training, onboarding, and other quality-related training as needed.
Support new product development and changes to existing products and processes.
What You Bring
Bachelor’s degree required; Engineering discipline preferred (Biomedical, Process, or Mechanical Engineering recommended).
Minimum 3 years’ experience in a quality role within a medical device company (or equivalent regulated manufacturing experience).
Professional certification in a quality discipline (e.g., Lead Auditor, CQE, CRE, Six Sigma) highly desirable.
Knowledge of quality concepts such as Risk Management, CAPA, Audits, and Statistics.
Understanding of applicable regulations (ISO 13485, FDA QSR, EU MDR) desired.
Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
Skills in formal investigation, root cause analysis, and process improvement preferred.
Process-based auditing experience preferred.
Ability to interpret engineering drawings and technical specifications.
Strong project management skills and the ability to influence without authority.
Why VB Spine? We believe in growing talent from within. At VB Spine, you’ll join a high-performing team, benefit from mentorship at all levels, and play a key role in advancing innovation in spinal care. Your work will have a direct impact on patient safety and surgical success.
Compensation Pay for this role is competitive and based on experience. Final compensation is determined on a case-by-case basis, considering skills, experience, and market conditions.
Benefits
Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunities to grow within a fast-paced, dynamic company
Apply for this job
First name
Last name
Email address
Location
Phone number
Resume Attach resume
Attach another file Attach file
What are your hours of availability?
What is your Linkedin Profile URL?
What is the name of your current employer?
Attach your Cover Letter - or: Attach Cover Letter
Cut and Paste your Cover Letter below:
What are your salary requirements?
Are you willing to relocate?
Are you authorized to work in the United States?
Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)?
What is your earliest start date?
Are you 18 years of age or older?
Do you have any professional qualifications (PMP, MCSE)?
What is the highest level of education you’ve obtained?
This role requires a HYBRID work schedule in which you need to be in the office 2-4 times a week depending on the needs of the business. Are you able to meet those requirements?
How did you hear about this position?
If you were referred, please list the name of the referring employee.
Do you have a non-compete that could impact your ability to work for VB Spine?
We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans\' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA.
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 Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.
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