Sr Quality Engineer

Job Description

Job Description

Job Description:

Job Title: Sr Quality Engineer

Location: Louisville, Colorado

Contract duration : 06+ months

Job description

Must Have Skills

• 3+ years of Medical Device industry experience.
• Strong experience with:
• • Non-Conforming Material Reports (NCMR)
  • CAPA
  • Product Quality Management
• Working knowledge of:
• • FDA 21 CFR Part 820
  • ISO 13485
  • EU MDR
  • Medical Device Quality Regulations
• Experience leading NCMR and CAPA investigations.
• Process Validation experience.
• Quality Management System (QMS) experience.
• Root Cause Analysis and Corrective Action implementation.
• Technical documentation and procedure writing skills.
• Project management capabilities.
• Excellent communication and stakeholder management skills.
• Proficiency with Microsoft Office Suite.

Nice to Have

• SAP
• Change Orders
• Nonconformance Management
• CAPA Systems
• Advanced Microsoft Applications

Top 3 Required Technical Skills

1. Technical procedure review and technical writing.
2. Strong understanding of FDA and ISO requirements related to NCMR/Nonconformance management.
3. Ability to effectively balance daily operational responsibilities with long-term quality initiatives.

Responsibilities

In the role of Sr. Quality Engineer , the individual will be responsible for:

• Reviewing and approving Non-Conformances (NCMR) , Document Changes , and Validations .
• Reviewing local QMS documents and comparing them against enterprise-level quality documents.
• Updating and harmonizing local QMS documentation to ensure compliance with Medtronic enterprise standards.
• Performing QMS Harmonization activities between local procedures and enterprise-level procedures.
• Leading Gemba Walks , documenting identified risks, and ensuring corrective actions are completed.
• Developing, modifying, applying, and maintaining quality standards and protocols for processing materials into partially finished or finished products.
• Collaborating with Engineering and Manufacturing teams to ensure quality standards are effectively implemented.
• Designing and implementing inspection, testing, and evaluation methods for products and manufacturing equipment.
• Conducting quality assurance testing and statistical analysis to determine root causes and responsibility for non-conforming materials or products.
• Ensuring corrective and preventive actions meet regulatory and quality requirements.
• Supporting quality activities related to:
• • Design Quality
  • Incoming Material Quality
  • Production Control
  • Product Evaluation & Reliability
  • Inventory Control
  • Research & Development Quality

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

Company Description

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.