Quality Assurance Engineer for Supplier Management

1 week ago


Santa Clara, California, United States Collabera Full time
Job Overview

We are looking for a skilled and proactive Quality Assurance Engineer to enhance our supplier quality processes. This position plays a crucial role in supporting product innovation, production, and service operations through the application of sophisticated quality engineering techniques. You will thrive in a collaborative, fast-paced environment where your contributions and teamwork will significantly impact the organization’s success.

Key Responsibilities:

  • Quality Program Design: Develop and sustain comprehensive programs for the systematic assessment and monitoring of projects, services, or facilities to ensure compliance with quality standards.
  • Process Oversight: Identify and implement robust process control mechanisms for product development and manufacturing to fulfill both internal and external requirements.
  • Leadership and Mentorship: Guide, coach, and mentor junior and entry-level personnel to enhance their competencies in quality engineering.
  • CAPA & Non-conformance Oversight: Spearhead the investigation, resolution, and prevention of product and process non-conformances using systematic problem-solving approaches.
  • Product Validation: Collaborate with design engineering teams to ensure thorough product verification and validation.
  • Risk Management: Lead the execution and upkeep of risk assessments, ensuring product safety and effectiveness.
  • Process Enhancement: Drive and implement methodologies for product and process improvements, including Six Sigma and Lean Manufacturing principles.
  • Data-Driven Analysis: Design and execute experiments for process optimization, documenting plans, protocols, and results.

Required Qualifications:

  • Education: Bachelor’s degree in Engineering or a related technical field, or equivalent experience.
  • Experience: 2-5 years of engineering experience, demonstrating proficiency in quality tools and methodologies.
  • Regulatory Acumen: Comprehensive understanding of FDA regulations, GMP, ISO 13485, and ISO 14971.
  • Skill Set: Strong project management, leadership, communication, and analytical skills.
  • Tools & Techniques: Familiarity with Six Sigma, Lean Manufacturing, and process improvement methodologies.
  • Collaboration: Ability to work effectively in a matrixed and geographically diverse setting, contributing both independently and as part of a team.
  • Travel Requirements: Occasional travel (0-10%) may be necessary.

Preferred Qualifications:

  • Advanced Education: Master’s degree in Engineering or a related discipline.
  • Certifications: ASQ Certified Quality Engineer (CQE) or other relevant quality certifications.
  • Medical Device Background: Previous experience in the medical device sector, particularly with catheter products.
  • Industry Knowledge: Familiarity with the Structural Heart domain, including heart valves and delivery systems, is advantageous.

Essential Skills for Success:

  • Biomedical or Manufacturing Expertise: Strong engineering foundation with experience in the biomedical or manufacturing sectors.
  • Detail Orientation: High level of precision and thoroughness in executing engineering tasks.
  • Flexibility: Ability to manage rapidly changing priorities and multitask effectively in a high-pressure environment.
  • Non-Conformance Documentation: Experience with non-conformance reports and Quality Process Improvement (QPI) documentation.

Compensation: $50/hr to $60/hr

Company Overview

Collabera is a Global Digital Solutions Company delivering Software Engineering Solutions for the world's most innovative organizations in Engineering, Cloud, and Data/AI. With a legacy of serving the engineering needs of leading businesses across Technology, Financial Services, Telecom, and Healthcare, Collabera operates in 60 locations across 11 countries, serving 30% of the Fortune 500, and has consistently outpaced the industry growth rate by 3-4x for several years.



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