Senior Engineer, Supplier Quality

Jobtailor; Cincinnati (OH); On-site; USD 95,000 - 130,000; Full time

Job summary

Jobtailor is seeking a Senior Supplier Quality professional to oversee the Approved Supplier List, qualification pathways, and QMS processes in a regulated environment.

You will lead audits, supplier evaluations, CAPA responses, and collaborate with the Enable team to improve documentation and compliance across FDA/ISO standards.

Qualifications

• Bachelor’s degree in Science, Health, or Engineering required.
• Minimum six years in a supplier-interacting role within a professional environment with an established QMS.
• Minimum six years in an FDA-regulated environment (or similar).
• Experience with ISO standards (ISO9001/13485/17025).
• Experience with 21CFR210/211/820 regulations.

Responsibilities

• Oversee Approved Supplier List (ASL) and drive continuous improvement of ASL activities.
• Guide Enable team on Supplier Qualification pathways in line with site procedures.
• Lead SCARs and Quality Alerts with Enable and suppliers.
• Schedule and document on-site or remote Quality audits.
• Lead supplier evaluation and performance documentation (Supplier Scorecards).
• Apply risk-based assessments for supplier classifications (GxP).
• Create and revise procedures to support Supplier Management and Enable.
• Manage CAPA/Nonconformances/Change Control activities and related documentation.
• Ensure traceability of supplier documents in SAP and other systems.
• Provide updates to leadership and escalate supplier-related challenges.

Skills

Supplier Qualification

Quality Auditing

CAPA

Documentation Accuracy

Traceability

Risk-Based Assessment

Regulatory Knowledge

Leadership

Education

Bachelor’s Degree (minimum) in Science, Health, or Engineering

Tools

SAP

Electronic Documentation Platforms

Job description

• Maintain oversight of the Approved Supplier List (ASL) and support continuous improvement of ASL activities (e.g. form efficiency, review and routing)
• Independently and / or collaboratively with the Manager, Supplier Quality, as needed or directed, provide guidance to the Enable team on the pathway for Supplier Qualification, consistent with site procedures
• Lead SCARs and / or Quality Alerts with the Enable team and suppliers to ensure robust documentation and closure
• Support and lead the scheduling, performance, and / or documentation of on-site and / or remote Quality audits
• Lead the supplier evaluation and performance documentation (e.g. Supplier Scorecards)
• Apply a risk-based perspective with an understanding of Critical, Major, Minor, or non-GxP classification, when assessing new or approved suppliers to Enable
• Create and revise procedures to support the Supplier Management department and Enable
• Drive or assist, as needed, with the responses and action implementation associated with CAPAs, Nonconformances, Quality Audits, Change Control / Change Management, and other QMS elements
• Ensure accuracy of all documentation, including traceability or linkage of supplier documentation in both physical and electronic platforms (e.g. paper and SAP)
• Provide routine updates to department leadership, including escalation of any supplier-related challenges (e.g. component quality concerns)
• Develop and nurture strong collaborative relationships with the Enable supplier network to support continuous improvement efforts
• Other duties as assigned

Requirements

• Bachelor’s Degree (minimum) in Science, Health, or Engineering
• A minimum of six (6) years of experience in a supplier – interacting role within a professional environment with an established QMS
• A minimum of six (6) years of experience in an FDA (or other Competent Authority) regulated environment
• Experience navigating Quality, Regulatory, and Industry standards in the medical device or pharmaceutical spaces
• Experience with ISO standards such as ISO9001, ISO13485, ISO17025, or others
• Experience with regulations such as 21CFR210, 21CFR211, or 21CFR820
• Experience with DQ / IQ / OQ / PQ and overall Process Validation (PV) navigation
• Auditor Certification (e.g. CQA, CMDA) or auditor experience (preferred)
• Experience with controlled environments, such as controlled room temperature, continuous monitoring, and cleanrooms or clean spaces (preferred)

Core Competencies

Demonstrates expertise in Supplier Quality Management, including oversight of Approved Supplier Lists, Quality Audits, and Supplier Evaluations. Proficient in navigating FDA regulations and ISO standards within the medical device or pharmaceutical industries.

Highest-signal resume keywords

• Supplier Quality Management
• FDA Regulated Environment Experience
• ISO Standards Knowledge
• Quality Auditing Skills
• Risk-Based Assessment

ATS Optimization Keywords

Hard Skills

• Supplier Qualification
• Quality Management System (QMS)
• Process Validation (PV)
• Supplier Scorecards
• Corrective and Preventive Actions (CAPA)
• Nonconformance Management
• Documentation Accuracy
• Traceability in Documentation
• Quality Alerts Management
• Supplier Evaluation

Soft Skills

• Collaborative Relationship Building
• Communication with Leadership
• Problem-Solving

Certifications & Qualifications

• Auditor Certification (CQA, CMDA)

Industry Keywords

• Medical Device
• Pharmaceutical
• ISO9001
• ISO13485
• ISO17025
• 21CFR210
• 21CFR211
• 21CFR820
• Controlled Environments
• Quality Regulatory Standards

Tools & Technologies

• SAP
• Electronic Documentation Platforms