Senior CAPA & Investigation Specialist - QMS Remediation

Job Title: Senior CAPA & Investigation Specialist - QMS Remediation
Location: Bedford, MA 01730
Contract Duration: 8 Months (Possibility of extension)
Pay: $70/Hr. on W2

Job Responsibilities:

• Leads and coordinates CAPA activities associated with QMS remediation efforts.
• Facilitates root cause investigations using structured problem-solving methodologies (5 Whys, Fishbone, Fault Tree Analysis, etc.).
• Evaluates the adequacy of containment, correction, corrective action, and preventive action plans.
• Partners with Quality, Regulatory, Engineering, Manufacturing, Service, and Clinical teams to execute remediation activities.
• Ensures CAPA documentation complies with internal procedures and regulatory expectations.
• Supports retrospective assessments, gap analyses, and remediation projects arising from audits, inspections, and quality system reviews.
• Tracks CAPA milestones, deliverables, and due dates to ensure timely closure.
• Develops objective evidence packages to support CAPA implementation and effectiveness.
• Performs effectiveness checks and verifies the sustainability of implemented actions.
• Supports preparation for FDA inspections, Notified Body audits, and internal quality reviews.
• Identifies trends and systemic quality issues requiring escalation or additional remediation actions.

Requirements:

• Minimum required Education: bachelor’s or master’s degree in mechanical engineering, Industrial Engineering, Science, or equivalent.
• Minimum required Experience: Minimum of 2 years of experience with a bachelor’s degree in areas such as Quality Management Systems, Quality Audits, or equivalent in highly regulated environments/industries (such as Medical Device, Pharma, or Automotive); OR no prior experience required with a Master's degree.
• Minimum required Certification: N/A

Preferred Qualifications & Skills:

• Preferred Education: N/A
• Preferred Experience: Experience supporting regulatory inspections, quality audits, or remediation programs is preferred.
• Preferred Certification: N/A

Preferred Skills:

• Strong technical writing and documentation skills.
• Ability to manage multiple CAPAs and remediation workstreams simultaneously.

Position Details:
Justification: Quality System Remediation.