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Process Validation Manager Jobs in Virginia (NOW HIRING)

Hayes Company LLC

Warehouse Lead

Sandston, VA · On-site

Perform quality assurance and inventory integrity functions such as slot profiling, inventory adjustments, cycle counts, audits, and process validation. * Manage exceptions including damages, strays ...

Hayes Company LLC

Warehouse Lead

Sandston, VA · On-site

Perform quality assurance and inventory integrity functions such as slot profiling, inventory adjustments, cycle counts, audits, and process validation. * Manage exceptions including damages, strays ...

Capital One

Manager, Process Management

Mclean, VA · On-site

Manager, Process Management At Capital One, we're building a leading information-based technology ... Creating and validating processes * Designing and producing metrics used to measure efficiency and ...

Socket.dev

Manager, Process Management

Mclean, VA · On-site

Manager, Process Management At Capital One, we're building a leading information-based technology ... Creating and validating processes * Designing and producing metrics used to measure efficiency and ...

Capital One

Manager, Process Management

Mclean, VA · On-site

Manager, Process Management At Capital One, we're building a leading information-based technology ... Creating and validating processes * Designing and producing metrics used to measure efficiency and ...

Capital One

Manager, Process Management

Richmond, VA · On-site

Manager, Process Management At Capital One, we're building a leading information-based technology ... Creating and validating processes * Designing and producing metrics used to measure efficiency and ...

THE ENTWISTLE COMPANY

PROCESS ENGINEER

Danville, VA

$80K - $110K/yr

Develop and approve technical documentation, including process validations and inspection methodologies, in coordination with Quality, Engineering, and Production Control teams. * Manage project ...

Entwistle Company

PROCESS ENGINEER

Danville, VA · On-site

$80K - $110K/yr

Develop and approve technical documentation, including process validations and inspection methodologies, in coordination with Quality, Engineering, and Production Control teams. * Manage project ...

ENTWISTLE COMPANY

PROCESS ENGINEER

Danville, VA · On-site

$80K - $110K/yr

... process validations and inspection methodologies, in coordination with Quality, Engineering, and Production Control teams. * · Manage project timelines, budgets, and compliance with safety and ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

Provide QA oversight for process validation activities to ensure processes are qualified ... Complete the bulk download of documents and records from a Quality Management System. Required ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

Provide QA oversight for process validation activities to ensure processes are qualified ... Complete the bulk download of documents and records from a Quality Management System. Required ...

Cadence Inc

Validation Engineer II

Staunton, VA · On-site

$83K - $105K/yr

Conduct risk assessments and manage change controls. * Ensure regulatory compliance. (GMP, GLP, CSV ... Contribute to process improvements and continuous improvement initiatives. Qualifications:

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Process Validation Manager information

What cities in Virginia are hiring for Process Validation Manager jobs?

Cities in Virginia with the most Process Validation Manager job openings:

Infographic showing various Process Validation Manager job openings in Virginia as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 17% Part Time, 3% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Client Manager - Medical Device QMS Auditor

Reston, VA • On-site

The British Standards Institution (BSI)
See more jobs at The British Standards Institution (BSI)external

$98K - $123K/yr

Full-time

Medical, Dental, Life, Retirement, PTO

Re-posted 2 days ago

Key responsibilities

  • Conduct audits of quality management systems, focusing on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities.

  • Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.

  • Prepare assessment reports, communicate findings to clients, and provide guidance for corrective actions.

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!
Job Title: Medical Device QMS Auditor
Location: Colorado
BSI (British Standards Institution) is the global business standards company that equips businesses with the solutions to turn standards of best practice into habits of excellence.
Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.
This is a travel-based position requiring extensive travel to medical device manufacturing sites, including approximately 13-15 overnight travel days per month.
Purpose of role: to conduct various types of audits and work closely with clients to help them improve their performance by assessing their systems and processes against BSI standards.
Essential Responsibilities
  • Analyze and assess quality management systems with emphasis on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities, ensuring compliance with ISO 13485, CE Marking, and MDSAP schemes.
  • Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.
  • Prepare assessment reports and communicate findings to clients, providing clear direction for corrective actions where appropriate.
  • Recommend the issue, re-issue, or withdrawal of certificates in accordance with BSI policies and procedures.
  • Lead assessment teams, ensuring quality of service and effective working relationships with clients and team members.

Education & Technical Qualifications
  • Technical degree (Associate's, Bachelor's, or higher) in Engineering, Science, or a related technical discipline required. Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials Science; Biology; Microbiology; Chemistry; or related technical fields applicable to medical devices, SaMDs, or IVDs.
  • Minimum of 4 years' experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating devices. Candidates must have personally worked with devices, specifications, or code, indicate the types and classifications of devices, and demonstrate their level of involvement on their CV. Regulatory or audit only experience is insufficient.
  • Detailed hands-on experience with design and manufacturing/production controls, including process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control.
  • Knowledge of regulatory requirements and quality management standards including ISO 13485, MDSAP, FDA QSR (21 CFR 820), and EU MDR/IVDR, are a plus.

Core Competencies
  • Strong verbal and written communication skills, and attention to detail.
  • Ability to work under pressure and meet deadlines.
  • Self-motivated, flexible, and excellent time management/planning skills.
  • Willingness to travel extensively.
  • Enthusiastic, committed team player.
  • Business development and public speaking skills are considered advantageous.

Preferred Qualifications
  • Experience with process validation, equipment qualification, and manufacturing process development.
  • Experience in design and development activities, including design controls and design transfer.
  • Hands-on experience with software-controlled medical devices, SaMD, or automated manufacturing systems.
  • Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking, and MDSAP.
  • Experience with risk management (ISO 14971), sterile medical devices, aseptic processing, or cleanroom manufacturing.
  • Experience leading hands-on teams in manufacturing, testing, or validation.
  • Lead Auditor certification (ISO 13485, MDSAP, or equivalent) preferred.
  • Previous experience working for a Notified Body, Regulatory Body, or Certification Body preferred.
  • Advanced degree (MS, PhD) in engineering, science, or related technical discipline preferred.

The salary for this position can range from $98,100 to $123,860 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
About Us
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues - from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

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