Valid8 Financial, Inc.
Sr. Staff NC/Capa Specialist
Valid8 Financial, Inc., Leesburg, Virginia, United States, 22075
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 and experienced Senior Staff NC/CAPA Specialist to oversee our NC/CAPA process, ensuring the highest standards of product and process quality. In this role, you’ll serve as a subject matter expert, mentor teams in structured problem-solving, and drive compliance, effectiveness, and continuous improvement across the organization.
What You’ll Do
Oversee NC/CAPA processes, ensuring compliance with procedures and regulations Review and approve NCs and CAPAs for accuracy, completeness, and effectiveness Mentor and guide teams through all stages of NC/CAPA, fostering problem-solving excellence Serve as eCAPA (Trackwise Digital) super-user and subject matter expert Lead NC/CAPA review boards, including multi-site and global forums Monitor KPIs, generate reports, and ensure compliance with global quality metrics Facilitate root cause analysis workshops and drive accountability in CAPA ownership Provide training on NC/CAPA processes and systems across the organization Support audits, inspections, and product hold processes Identify and drive continuous improvement initiatives in quality systems What You Bring
Bachelor’s degree in science, engineering, or related discipline (Master’s, CQE, or CRE preferred) Minimum of 6 years’ experience in the medical device or other regulated industry Demonstrated expertise leading NC/CAPA processes Direct experience with FDA and Notified Body interactions Strong knowledge of US, EU, and international medical device regulations Applied experience with quality tools such as FMEA, GD&T, root cause analysis, and mistake-proofing/poka yoke Six Sigma Green or Black Belt certification preferred Familiarity with product development lifecycle, risk management, and design/process validation Strong project management, analytical, and problem-solving skills Excellent communication, facilitation, and cross-functional collaboration abilities Proficiency in Minitab or similar analysis software; Trackwise Digital experience preferred Confident in presenting to large groups 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 help shape quality strategy in the dynamic medical device industry—positioning yourself to influence innovation and patient outcomes worldwide. Compensation
Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. The typical pay range for this position is $140,000 - $155,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers experience level, skillset, and market conditions. Benefits
Comprehensive health, dental, and vision insurance 401(k) with company match PTO and holidays Ongoing training and professional development opportunities Opportunity to grow within a fast-paced, mission-driven company Apply for this job
First name Last name Email address Location Phone number Resume Attach another file What are your hours of availability? monday tuesday wednesday thursday friday saturday sunday What is your LinkedIn Profile URL? What is the name of your current employer? 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 personal website or portfolio URL? 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. GENDER Male Female Nonbinary I do not wish to self-identify my gender ETHNICITY American Indian/Alaska Native (Not Hispanic or Latino) Asian (Not Hispanic or Latino) Black/African American (Not Hispanic or Latino) Hispanic/Latino Native Hawaiian/Other Pac Island (Not Hispanic or Latino) White (Not Hispanic or Latino) Two or More Races (Not Hispanic or Latino) Decline to Specify 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. Disabled Veteran Armed Forces Service Medal Veteran Veteran who served on active duty during a war or in a campaign or expedition for which a campaign badge has been authorized Recently Separated Veteran Veteran, but not one of the four protected classes above I decline to state my veteran status Not a Veteran 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. Yes, I Have A Disability, Or Have A History/Record Of Having A Disability No, I Don’t Have A Disability, Or A History/Record Of Having A Disability I Don’t Wish To Answer
#J-18808-Ljbffr
Oversee NC/CAPA processes, ensuring compliance with procedures and regulations Review and approve NCs and CAPAs for accuracy, completeness, and effectiveness Mentor and guide teams through all stages of NC/CAPA, fostering problem-solving excellence Serve as eCAPA (Trackwise Digital) super-user and subject matter expert Lead NC/CAPA review boards, including multi-site and global forums Monitor KPIs, generate reports, and ensure compliance with global quality metrics Facilitate root cause analysis workshops and drive accountability in CAPA ownership Provide training on NC/CAPA processes and systems across the organization Support audits, inspections, and product hold processes Identify and drive continuous improvement initiatives in quality systems What You Bring
Bachelor’s degree in science, engineering, or related discipline (Master’s, CQE, or CRE preferred) Minimum of 6 years’ experience in the medical device or other regulated industry Demonstrated expertise leading NC/CAPA processes Direct experience with FDA and Notified Body interactions Strong knowledge of US, EU, and international medical device regulations Applied experience with quality tools such as FMEA, GD&T, root cause analysis, and mistake-proofing/poka yoke Six Sigma Green or Black Belt certification preferred Familiarity with product development lifecycle, risk management, and design/process validation Strong project management, analytical, and problem-solving skills Excellent communication, facilitation, and cross-functional collaboration abilities Proficiency in Minitab or similar analysis software; Trackwise Digital experience preferred Confident in presenting to large groups 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 help shape quality strategy in the dynamic medical device industry—positioning yourself to influence innovation and patient outcomes worldwide. Compensation
Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. The typical pay range for this position is $140,000 - $155,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers experience level, skillset, and market conditions. Benefits
Comprehensive health, dental, and vision insurance 401(k) with company match PTO and holidays Ongoing training and professional development opportunities Opportunity to grow within a fast-paced, mission-driven company Apply for this job
First name Last name Email address Location Phone number Resume Attach another file What are your hours of availability? monday tuesday wednesday thursday friday saturday sunday What is your LinkedIn Profile URL? What is the name of your current employer? 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 personal website or portfolio URL? 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. GENDER Male Female Nonbinary I do not wish to self-identify my gender ETHNICITY American Indian/Alaska Native (Not Hispanic or Latino) Asian (Not Hispanic or Latino) Black/African American (Not Hispanic or Latino) Hispanic/Latino Native Hawaiian/Other Pac Island (Not Hispanic or Latino) White (Not Hispanic or Latino) Two or More Races (Not Hispanic or Latino) Decline to Specify 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. Disabled Veteran Armed Forces Service Medal Veteran Veteran who served on active duty during a war or in a campaign or expedition for which a campaign badge has been authorized Recently Separated Veteran Veteran, but not one of the four protected classes above I decline to state my veteran status Not a Veteran 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. Yes, I Have A Disability, Or Have A History/Record Of Having A Disability No, I Don’t Have A Disability, Or A History/Record Of Having A Disability I Don’t Wish To Answer
#J-18808-Ljbffr