Quality Engineer

Job Description – FDA Remediation Manufacturing Engineer / Quality Engineer
Location: Marlborough, MA
Industry: Medical Devices
Duration: 6 Months

Position Summary
Client is hiring experienced Manufacturing Engineers and Quality Engineers to support FDA remediation activities within a medical-device manufacturing environment.
The ideal candidates will have strong experience in medical-device manufacturing, quality engineering, FDA remediation, deviation investigations, Root Cause Analysis (RCA), CAPA, and process improvement. Candidates with experience supporting regulated manufacturing operations and resolving complex quality/compliance issues are preferred.

Key Responsibilities
Support FDA remediation activities related to manufacturing and quality processes.
Investigate manufacturing deviations, nonconformances, and quality issues.
Perform detailed Root Cause Analysis (RCA) and identify systemic and contributing causes.
Develop, implement, and track CAPA activities through successful closure.
Evaluate manufacturing processes and identify opportunities to improve compliance, quality, and process robustness.
Support remediation of quality-system and manufacturing gaps identified through FDA, internal, or external audits.
Partner with Manufacturing, Quality, Engineering, Validation, and Operations teams to implement corrective actions.
Support process improvements, process validation, equipment qualification, and manufacturing readiness activities as applicable.
Review and update manufacturing procedures, work instructions, specifications, and technical documentation.
Analyze quality and manufacturing data to identify trends, recurring issues, and potential risks.
Participate in risk assessments, change controls, investigations, and corrective-action activities.
Prepare technical reports, investigation documentation, CAPA records, remediation documentation, and supporting engineering documentation.
Monitor remediation action items and ensure activities are completed within established timelines.
Support audit and regulatory inspection readiness.

Required Qualifications
Bachelor's degree in Engineering, Quality, Manufacturing Engineering, Mechanical Engineering, or a related technical field.
Strong experience in the medical-device industry.
Experience with FDA remediation activities.

Hands-on experience with:
Root Cause Analysis
Deviation Investigations
CAPA
Nonconformances/NCRs
Corrective and Preventive Actions
Change Control
Risk Assessment
Process Improvement
Strong understanding of FDA medical-device requirements and Quality Management Systems.
Experience working with cross-functional Manufacturing, Quality, Engineering, and Operations teams.
Strong technical documentation and problem-solving skills.
Ability to independently investigate complex manufacturing and quality issues.

Preferred Qualifications
10+ years of experience in Manufacturing Engineering, Quality Engineering, or related regulated manufacturing functions.
Experience with FDA 483, Warning Letter, audit findings, or remediation programs.
Experience with FDA 21 CFR Part 820/QMSR and ISO 13485.
Experience with process validation and equipment qualification.
Experience in sterile/aseptic or controlled manufacturing environments is a plus.
Lean/Six Sigma experience or certification preferred.
Experience supporting regulatory inspections and quality-system remediation.

Ideal Candidate Profile
We are particularly interested in candidates with:
Medical Device Manufacturing + FDA Remediation + RCA + Deviation Investigation + CAPA + Quality/Manufacturing Engineering
Candidates with 10+ years of experience and a strong track record of resolving complex manufacturing and quality issues in FDA-regulated medical-device environments are preferred.