Supplier Quality Engineer / Process Engineer - Medical Device Industry

Job Description

Job Description

Position Overview

The Supplier Engineer is responsible for ensuring suppliers reliably support plant production by meeting company requirements for quality, delivery, capacity, cost, and service. This role is highly execution-focused and serves as the primary technical interface between the plant and suppliers to resolve line-impacting issues, improve supplier manufacturing processes, and maintain stable production operations across multiple product families.

The Supplier Engineer partners closely with Manufacturing, Quality, Planning, Operations, Design Engineering, Commodity / Supply Chain Engineering, and Procurement to drive supplier performance, qualify manufacturing processes, support New Product Introduction (NPI), and execute continuous improvement initiatives across the supply base.

This position owns supplier performance for assigned commodities and components supporting plant production, with direct accountability for issue resolution, process capability, risk mitigation, and long-term supplier health.

Essential Job Duties & Responsibilities

Supplier Performance & Plant Support

Serve as the primary technical interface between plant manufacturing teams and suppliers for quality issues, line disruptions, yield loss, delivery concerns, and capacity constraints.

Lead supplier issue resolution from containment through root cause investigation and corrective/preventive action implementation.

Support manufacturing operations by investigating and resolving supplier-related deviations, variances, nonconformances, and first article issues.

Monitor supplier performance across quality, delivery, responsiveness, and manufacturing stability, driving improvement where gaps exist.

Support uninterrupted production by proactively managing supplier risks and escalating critical issues appropriately.

Supplier Manufacturing Process Improvement

Work directly with suppliers to improve manufacturing processes, process capability, inspection methods, and process controls.

Drive sustainable corrective actions using structured problem-solving methodologies and data-driven analysis.

Lead investigations into recurring defects, quality escapes, process variation, and manufacturing inefficiencies impacting production.

Partner with suppliers to improve yield, reduce variability, and strengthen manufacturing robustness.

Build and execute supplier development plans using Lean Manufacturing, Six Sigma, SPC, and continuous improvement principles.

Supplier Qualification, Validation & Change Management

Own and execute supplier qualification and validation activities, including:

Supplier pFMEA

IQ/OQ/PQ and process validations

First Article Inspections and inspection reports

Gage R&R and process capability analysis (Cp/Cpk)

Support execution and closure of Variance Requests (VRs), Supplier Change Requests (SCRs), and supplier-driven manufacturing changes.

Approve and manage supplier process changes including new equipment, process transfers, facility moves, tooling changes, and production line validations.

Support implementation of ECO changes impacting suppliers, ensuring validation and risk mitigation prior to production release.

Assess supplier readiness and manufacturing capability to support sustaining production and NPI ramp activities.

Risk Mitigation & Operational Excellence

Identify and proactively manage supplier-related risks including quality, capacity, continuity, and manufacturing constraints.

Convert recurring supplier issues into structured improvement initiatives to eliminate root causes.

Drive continuous improvement projects focused on quality, operational efficiency, manufacturing consistency, and supply continuity.

Generate and track supplier performance metrics and provide data-driven recommendations to improve supplier health and performance.

Support supplier audits, process reviews, and operational assessments as required.

Cross-Functional Partnership & Communication

Partner closely with Manufacturing, Quality, Supply Chain, Planning, Procurement, and Engineering teams to support plant objectives.

Communicate supplier risks, issue status, recovery plans, and project updates clearly to cross-functional teams and leadership.

Support New Product Introduction (NPI) activities by evaluating supplier readiness, process capability, validation strategy, and production ramp risk.

Maintain strong supplier relationships to effectively partner between company and the supply base.

Provide technical recommendations and supplier performance updates with minimal supervision.

Perform other related duties as assigned.

Required Qualifications

Education & Experience

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Electrical Engineering, or equivalent technical discipline

Minimum 2–5 years of experience in Supplier Engineering, Manufacturing Engineering, Quality Engineering, Supplier Quality, or related field

Experience supporting high-volume manufacturing environments, preferably in medical devices or regulated industries

Hands-on experience with manufacturing processes such as machining, MIM, injection molding, stamping, extrusion, or assembly processes preferred

Experience supporting New Product Introduction (NPI) and production scaling preferred

Technical Skills & Systems

Strong technical problem-solving and root cause investigation skills

Working knowledge of pFMEA, process validation, statistical analysis, SPC, inspection methodologies, and corrective action systems

Familiarity with Lean Manufacturing and Six Sigma methodologies

Proficiency in Microsoft Excel, Word, and Project

Experience with ERP and document management systems such as SAP and Agile preferred

Experience with Minitab or statistical analysis software preferred

CAD / 3D modeling experience is a plus

Additional Skills

Strong analytical, organizational, and communication skills

Ability to manage multiple priorities in a fast-paced manufacturing environment

Demonstrated ability to work cross-functionally and influence without direct authority

Ability to travel domestically and internationally as needed (approximately 25%)

Preferred Qualifications

Knowledge of 21 CFR Part 820 and ISO 13485 preferred

Six Sigma certification or Lean Manufacturing certification preferred

Experience working directly with external suppliers and contract manufacturers preferred

Experience supporting production issue escalation and supplier recovery activities preferred

Company DescriptionDella Infotech Inc is in the staffing business for 10 years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations.

Company Description

Della Infotech Inc is in the staffing business for 10 years. Over the years, we have placed hundreds of candidates to various temp and permanent positions with our 50+ happy clients all over US and Canada including Fortune 500 corporations.