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Quality Engineer 2

Sunrise Systems Inc
  • 🇺🇸 United States
  • On-site
  • 3 weeks ago
  • Risk Management
  • CAPA
  • Change Management
  • Lean Six Sigma
  • Kaizen
  • FMEA
  • SPC
  • Regulatory Compliance
  • GMP
  • Technical Writing
  • Microsoft Office Applications
3 weeks ago
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Our client, a leadingMedical Device Manufacturing Company is looking forQuality Engineer 2and This is for an initial duration of04 MonthsContract –El Paso, TX
 
Job Title: Quality Engineer 2
Job Id: 26-04619
Location: El Paso, TX
Duration: 04 Months Contract
Position Type: Hourly Contract Position (W2 only)

Job Description 
  • Temp to perm possibility On Site
  • Responsible for ensuring that suppliers consistently provide materials, components, and services that meet CLIENT quality, regulatory, and operational requirements. This role partners closely with suppliers and cross-functional teams including Procurement, Operations, Manufacturing Engineering, R&D, Quality, and Technical Operations to drive supplier performance, manage supplier-related risks, support product and process improvements, and ensure compliance with applicable regulations and standards.
  • The SQE will lead supplier quality initiatives, supplier qualification activities, investigations, corrective actions, audits, and risk management efforts to support business continuity and product quality.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Supplier Quality Management 
  • Collaborate with suppliers and internal business partners to ensure robust materials, products, processes, and quality systems.
  • Manage supplier quality performance through data analysis, trend monitoring, and risk assessment activities.
  • Identify supplier quality risks and drive mitigation plans to minimize business disruptions.
  • Develop and maintain Supplier Quality Agreements in collaboration with suppliers and Supplier Quality leadership.
  • Lead supplier performance improvement initiatives and supplier development activities.
Supplier Audits and Compliance 
  • Plan, execute, document, and follow up on supplier quality system audits.
  • Evaluate supplier compliance with FDA regulations, ISO standards, and CLIENT Quality System requirements.
  • Assess supplier quality systems and manufacturing controls to ensure continued compliance.
  • Support supplier qualification and requalification activities.
Investigations and Corrective Actions 
  • Lead and support supplier-related root cause investigations.
  • Drive supplier Corrective and Preventive Actions (CAPA) and Supplier Corrective Action Requests (SCARs).
  • Ensure effective implementation and verification of corrective actions.
  • Escalate critical supplier quality issues when intervention is required.
Change Management 
  • Manage supplier change notifications and change control activities.
  • Coordinate impact assessments for supplier and material changes.
  • Support supplier transitions, component qualifications, and validation activities.
  • Partner with cross-functional teams to ensure timely approval and implementation of changes.
Continuous Improvement 
  • Lead supplier quality improvement projects with minimal supervision.
  • Apply Lean, Six Sigma, and Performance Excellence tools to improve supplier performance and process capability.
  • Utilize methodologies such as: DMAIC, Kaizen, Value Stream Mapping (VSM), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis (RCA), Measurement System Analysis (MSA), Statistical Process Control (SPC), Capability Analysis (Cp/Cpk/Ppk), Design of Experiments (DOE)
Cross-Functional Collaboration 
  • Partner with Procurement, Manufacturing, Operations, Engineering, Technical Operations, and R&D teams to investigate and resolve supplier-related quality issues.
  • Support new product introduction (NPI) and component qualification projects.
  • Participate in risk management and product improvement efforts.
  • Communicate supplier quality issues, trends, and opportunities to management.
Quality and Regulatory Compliance 
  • Ensure compliance with: FDA 21 CFR Part 820, ISO 13485, ISO 14971, CLIENT Quality System Requirements, Environmental, Health & Safety policies
  • Support FDA inspections and external regulatory audits.
  • Maintain accurate documentation in accordance with ALCOA+ principles and good documentation practices.
Education and Experience: 
  • Bachelor's degree in Engineering or related field.
  • 5 years Supplier Quality and/or Supplier Development
  • Understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements
  • Prior Supplier Quality experience in a manufacturing plant or technical background
  • Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.)
Knowledge and Skills: 
  • Bilingual professional with strong verbal and written communication skills in both English and Spanish.
  • Demonstrated knowledge of manufacturing principles and practices, and procedures
  • Direct experience in plant and/or supplier GMP auditing
  • Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA/SCAR systems and investigations, production and process controls
  • Experience with documentation and technical writing skills, in a regulated compliance environment
  • Demonstrated ability to identify compliance risks and assess business impact
  • Ability to manage complexity and lead critical discussions
  • Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches
  • Strong analytical and problem-solving abilities.
  • Ability to assess compliance risks and business impact.
  • Excellent project management and organizational skills.
  • Ability to manage complexity and influence cross-functional teams.
  • Strong verbal and written communication skills.
  • Ability to lead critical discussions with suppliers and business leaders.
  • Proficient in Microsoft Office applications and quality management systems.
Physical Demands: (if applicable)
Work Environment: (if applicable) 
  • May require periodic travel to supplier facilities for audits, assessments, supplier development activities, and project support.
  • The role operates in a regulated medical device manufacturing environment and requires adherence to all applicable CLIENT quality, safety, and compliance requirements
Qualified candidates please send your word format updated resume at the earliest to Pavan:Pavan.p@sunrisesys.com [732-395-4444].
 
Thank You.

Quality Engineer 2 · Sunrise Systems Inc

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