Supplier Quality Engineer

Full-timeMIDEngineering
Market Rate — Chemical Engineers
25th
$92K
Median
$112K
75th
$139K

BLS 2024 data (national)

Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Responsibilities:

  • Qualification, evaluation, and continuous monitoring of suppliers in accordance with ISO 9001 requirements, applying risk-based supplier classification and performance management principles;
  • Ensuring that supplier controls meet the expectations of customers operating under ISO 13485 and/or GMP environments;
  • Management of supplier-related nonconformities, including structured root cause analysis, corrective actions, and effectiveness verification;
  • Oversight of externally provided processes with focus on documentation control, traceability, validation support, and compliance-relevant records;
  • Evaluation and approval of supplier change notifications, including structured risk assessment and customer impact analysis;
  • Driving supplier quality performance improvement through KPI monitoring, escalation management, and development initiatives;
  • Planning and execution of supplier audits when required, including preparation for customer audits and support during external inspections.

Requirements:

  • Degree in Engineering, Quality Management, or a related technical discipline;
  • Proven experience in supplier quality management within an ISO 9001 certified environment;
  • Solid understanding of ISO 13485 and/or GMP requirements, particularly regarding supplier control, documentation, traceability, and regulatory expectations;
  • Strong knowledge of quality tools and methodologies such as FMEA, 8D, Root Cause Analysis, risk assessment, and statistical methods;
  • Experience with nonconformance management, CAPA processes, risk-based thinking, and structured change control;
  • High level of self-organization, engagement, and ability to collaborate effectively in cross-functional and customer-facing environments;
  • Strong analytical skills, structured working style, and a clear sense of ownership and accountability;
  • Proficiency in Microsoft 365 applications (Excel, Word, PowerPoint, Teams) and experience with quality management or ERP systems;
  • Fluent English in written and spoken communication.

We offer:

  • Competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits;
  • Employment with an innovative, forward-thinking organization, and outstanding career and development prospects;
  • Exciting company culture that stands for integrity, intensity, involvement, and innovation.

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EngineeringWroclaw, Poland
TF

Thermo Fisher Scientific

OTHER

LocationWALTHAM, MA
Employees50000+
Open Jobs1998

Pipeline

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Blood samplingN/A
RimegepantN/A