CAPA Quality Engineer

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: CAPA Quality Engineer

Location(s): Murrysville, PA or Cambridge, MA
(Hybrid)

Position Overview:
Seeking an experienced Quality Engineer to lead and manage Corrective and Preventive Action (CAPA) activities in a regulated medical device environment. This role supports the improvement and maintenance of the CAPA program by driving investigations, root cause analysis, corrective actions, and effectiveness monitoring. The position requires strong project management, quality systems, and cross-functional leadership skills.

Key Responsibilities:

• Facilitate CAPA investigations from issue identification through implementation and effectiveness verification.
• Independently create, manage, and complete CAPA records.
• Project manage CAPA activities, including timelines, deliverables, stakeholder coordination, and resource management.
• Lead cross-functional teams in root cause analysis and problem-solving activities using structured methodologies.
• Assess issue descriptions, review quality data sources, and conduct detailed investigations.
• Analyze quality and performance data using statistical techniques to identify trends and causes of nonconformances.
• Develop and implement corrective and preventive actions to address quality issues.
• Present CAPA status and outcomes during audits and CAPA Review Board meetings.
• Collaborate with management and business stakeholders to secure support, resources, and implementation plans.
• Evaluate complex product, software, hardware, and process-related quality issues.
• Ensure compliance with applicable regulatory and quality system requirements.

Required Qualifications:

• Bachelor's degree in Engineering with 5+ years of related experience, or
• Master's degree in Engineering with 3+ years of related experience.
• Experience managing CAPA processes within a regulated industry, preferably medical devices.
• Strong root cause analysis and quality problem-solving skills.
• Experience leading cross-functional teams and driving investigation activities.
• Strong project management capabilities.
• Ability to analyze data and apply statistical methods.
• Excellent written and verbal communication skills.

Preferred Knowledge:

• FDA Quality System Regulations, including:
  • 21 CFR Part 803
  • 21 CFR Part 806
  • 21 CFR Part 820
• ISO 13485
• ISO 9001
• ISO 14971
• Quality systems, risk management, and regulatory compliance requirements.

Business Need:
These resources are being added to support remediation efforts, strengthen the CAPA program, and help maintain compliance and operational effectiveness following regulatory requirements.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.