Quality Engineer Remediation

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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