Quality Engineer– Remediation/ PHIAJP00004374
Duration: 7 months
2 positions
Location: Bedford MA
Project Focus: Remediation of FDA Observations
Job Type: Contract
Job Summary
The Quality Engineering Contractor will support remediation activities related to FDA observations at the Bedford, MA facility. This role focuses on manufacturing quality, non-conformance management, CAPA, process validation, continuous improvement, and regulatory compliance. The contractor will collaborate with Manufacturing, Supplier Quality, Purchasing, and other cross-functional stakeholders to address quality issues, strengthen manufacturing processes, and maintain effective quality systems.
Key Responsibilities
1. Quality Systems and FDA Remediation
• Support remediation activities related to FDA observations and help ensure compliance with applicable regulatory requirements.
• Maintain manufacturing quality systems and facilitate timely completion of Quality Engineering (QE) and Quality Assurance (QA) activities.
• Manage non-conformance events and investigations within the factory.
• Support the implementation of effective Corrective and Preventive Actions (CAPA).
2. Non-Conformance Management and Root Cause Analysis
• Lead defect analysis to determine appropriate dispositions for non-conforming products and materials.
• Drive the management of Non-Conformances (NCs) and Quality Notifications (QNs).
• Facilitate root cause investigations and implementation of effective corrective actions.
• Guide Material Review Board (MRB) activities related to non-conformance disposition management.
3. Process Validation and Manufacturing Engineering
• Lead process validation protocols and facilitate production builds to support validation activities.
• Conduct single-process or complex process validation activities, as well as process improvement initiatives.
• Analyze validation data and prepare reports to support process improvements and quality decisions.
• Support Manufacturing Process Development and Design Transfer activities.
• Assess the impact of design changes on Process Failure Mode and Effects Analysis (PFMEA) and associated process controls.
4. New Product Introduction and Supplier Quality
• Support New Product Introduction (NPI), product transfers, and manufacturing readiness activities.
• Collaborate with Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA), Purchasing, and analytical testing teams.
• Maintain effective relationships with suppliers and internal stakeholders.
• Apply previous NPI experience to support successful product and process transitions.
5. Data Analysis and Continuous Improvement
• Monitor manufacturing operational performance, prepare reports, and identify improvement opportunities.
• Apply advanced statistical analysis methods to interpret complex data trends and resolve quality-related issues.
• Use data-driven insights to improve manufacturing quality, process efficiency, and compliance.
• Facilitate factory improvement programs using Quality Engineering and Continuous Improvement techniques.
• Communicate quality metrics, performance trends, achievements, and recommended actions to stakeholders.
6. Technical Leadership and Training
• Provide technical guidance to colleagues and help resolve technical problems.
• Develop and manage schedules and performance requirements; budget responsibilities may also apply.
• Deliver specialized training on quality standards, methodologies, and best practices.
• Influence cross-functional projects and peer groups while fostering effective working relationships.
Minimum Qualifications
Education
• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or an equivalent field.
Experience
• With a Bachelor's degree: Minimum of 2 years of experience in Quality Engineering, Safety Engineering, Process Engineering, or an equivalent area.
• With a Master's degree: No prior experience required.
Certifications
• No specific certification required.
Preferred Skills and Competencies
• Process Quality Management
• Data Analysis and Interpretation
• Design for Quality (DFQ)
• Root Cause Analysis (RCA)
• Corrective and Preventive Action (CAPA) methodologies
• Regulatory Requirements and Compliance
• Manufacturing Processes
• Process Monitoring
• Risk Assessment
• Technical Documentation
• Process Engineering
• Continuous Improvement
• Privacy, Safety, and Security
Additional Project Context
The contractor will support remediation of FDA observations at the Bedford, MA facility. Candidates with relevant manufacturing quality experience and demonstrated expertise in non-conformance investigations, CAPA, process validation, and regulatory remediation should be prioritized.
Thanks,
Amit Sehdev
APN Software Services Inc.
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