Principal Quality Engineer - Medical Device - W2

Summary

Job Title: Senior / Principal Quality Engineer – FDA Remediation

Job Type: Contract – Initial 6 Months, Potential Extension

Location: Glens Falls, NY | Waukegan / Mundelein / Northfield, IL

Work Arrangement: Hybrid

Job Description:

We are seeking experienced Senior / Principal Quality Engineers to support FDA compliance and remediation programs within a regulated medical device or pharmaceutical manufacturing environment. Candidates must be hands-on, capable of independently executing CAPA activities, remediating quality documentation, and driving compliance actions through closure.

Key Responsibilities:

• Execute CAPA and FDA remediation activities according to established plans.
• Review and remediate Risk Management Files, Design History Files (DHF), and design control documentation.
• Review technical files, test reports, validation protocols, and historical product records.
• Update SOPs, procedures, work instructions, and Quality System documentation.
• Identify documentation gaps and implement corrective actions.
• Collaborate with Quality, Engineering, Manufacturing, and Regulatory teams.
• Track remediation deliverables and meet FDA commitment deadlines.

Required Skills:

• Senior-level Quality Engineering / Quality Systems experience
• CAPA execution and closure
• FDA compliance and remediation
• Medical Device / Pharmaceutical / Regulated Manufacturing
• Quality Management Systems (QMS)
• Technical Documentation Review and Remediation
• Strong Technical Writing and Problem-Solving Skills

Preferred Skills:

• Risk Management Files and Design History Files (DHF)
• Design Controls and FDA Warning Letter Remediation
• Manufacturing Quality and Validation Documentation
• Legacy Medical Device / Product Remediation
• SOP and Quality System Remediation
• Education: Bachelor's degree in Engineering, Science, Quality, or a related technical field.

Job Description

Job Title: Senior / Principal Quality Engineer – FDA Remediation

Job Type: Contract – Initial 6 Months, Potential Extension

Location: Glens Falls, NY | Waukegan / Mundelein / Northfield, IL

Work Arrangement: Hybrid

Job Description:

We are seeking experienced Senior / Principal Quality Engineers to support FDA compliance and remediation programs within a regulated medical device or pharmaceutical manufacturing environment. Candidates must be hands-on, capable of independently executing CAPA activities, remediating quality documentation, and driving compliance actions through closure.

Key Responsibilities:

• Execute CAPA and FDA remediation activities according to established plans.
• Review and remediate Risk Management Files, Design History Files (DHF), and design control documentation.
• Review technical files, test reports, validation protocols, and historical product records.
• Update SOPs, procedures, work instructions, and Quality System documentation.
• Identify documentation gaps and implement corrective actions.
• Collaborate with Quality, Engineering, Manufacturing, and Regulatory teams.
• Track remediation deliverables and meet FDA commitment deadlines.

Required Skills:

• Senior-level Quality Engineering / Quality Systems experience
• CAPA execution and closure
• FDA compliance and remediation
• Medical Device / Pharmaceutical / Regulated Manufacturing
• Quality Management Systems (QMS)
• Technical Documentation Review and Remediation
• Strong Technical Writing and Problem-Solving Skills

Preferred Skills:

• Risk Management Files and Design History Files (DHF)
• Design Controls and FDA Warning Letter Remediation
• Manufacturing Quality and Validation Documentation
• Legacy Medical Device / Product Remediation
• SOP and Quality System Remediation
• Education: Bachelor's degree in Engineering, Science, Quality, or a related technical field.