CAPA Coordinator

Job Summary

Randstad Digital is partnering with a leading manufacturer of consumer goods and medical devices to find a CAPA coordinator that will help support validation plans and design control processes. Apply today!

location: Telecommute

job type: Contract

salary: $95 - 105 per hour

work hours: 8am to 5pm

education: Bachelors

Responsibilities

Strategizes and oversees the development and execution of comprehensive process validation plans, leveraging advanced statistical methodologies to ensure the seamless and regulatory-compliant transition of new products into full-scale production.

• Leads and directs the entire design control process, ensuring that all stages from eliciting and validating design inputs to verification, validation, and design transfer are executed with strict adherence to global regulatory requirements and the highest quality standards.
• Champions the adoption and optimization of advanced Quality Engineering practices across cross-functional teams, utilizing deep expertise in products and services to foster a culture of continuous improvement and excellence in quality management.
• Spearheads strategic quality improvement initiatives, integrating insights from Post Market Surveillance (PMS), quality, and reliability data into all stages of the product lifecycle, driving ongoing enhancements in product quality and regulatory compliance.
• Directs comprehensive evaluations of product and system designs, leading critical reviews of performance data and root cause analyses to proactively identify and address quality deficiencies, ensuring design excellence and compliance with regulatory standards.
• Leads organizational preparation for and response to systems design audits and inspections, providing strategic oversight and expert guidance to demonstrate unwavering adherence to internal and external quality standards, and driving improvements in audit readiness.
• Enforces the validation of critical design inputs, such as usability, reliability, performance, manufacturability, and safety, ensuring that all design aspects are rigorously aligned with stringent quality and regulatory requirements.
• Oversees and directs comprehensive risk management activities throughout the product lifecycle, ensuring that risks are systematically identified, assessed, and mitigated to protect product safety, quality, and regulatory integrity.
• Utilizes post-market performance data to lead in-depth assessments of product effectiveness in the field, providing strategic direction to manufacturing and design teams, and initiating high-impact corrective actions and continuous improvements.
• Ensures organizational readiness for quality audits and inspections, directing the maintenance and oversight of all necessary documentation and processes to achieve full compliance with internal and external quality standards.
• Leads the CAPA process at a strategic level, overseeing the identification of issues, conducting thorough root cause analyses, and driving the implementation of comprehensive solutions to prevent recurrence, thereby enhancing overall quality systems.
• Drives continuous improvement initiatives across the organization, applying advanced quality management techniques to ensure ongoing audit readiness, adherence to internal and external standards, and proactive quality assurance throughout the product lifecycle.
• Cultivates and strengthens strategic relationships with internal and external stakeholders, providing high-level mentorship, guidance, and leadership to cross-functional teams, ensuring alignment with quality standards, regulatory requirements, and the successful achievement of critical project milestones. Leads succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.
  
  

Qualifications

Minimum required Education:

• Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
  
  

Minimum Required Experience

• Minimum 8 years of experience with Bachelor's OR Minimum 6 years of experience with Master's in areas such as Quality Engineering, R&D Engineering or equivalent.
  
  

Preferred Certification

• Six Sigma Green Belt
  
  

Preferred Skills

• Design Quality Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• Root Cause Analysis (RCA)
• CAPA Methodologies
• Regulatory Requirements Privacy,
• Safety and Security
• Risk Assessment
• Technical Documentation
• Continuous Improvement
• Budget Management
• Product Quality and Reliability
• Product Lifecycle Management (PLM)
• Business Acumen
• People Management
• Defect Management
• Design Verification Planning
• Design Validation Planning
• Product Test Design
  
  

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.