Associate Quality Engineer at Abbott Vascular
Overview
Develop and maintain quality engineering methodologies while supporting manufacturing or system services. Lead process control systems and CAPA initiatives to meet regulatory standards. Drive continuous improvement through Six Sigma and Lean Manufacturing. Collaborate across cross‑functional teams to resolve quality issues and ensure compliance with FDA and ISO requirements. This is an onsite daily required position in Houston Texas offering competitive compensation and growth opportunities.
What You'll Do11
- 1Design and implement process control systems to support product development and ongoing manufacturing
- 2Lead assurance, process controls, and CAPA systems to satisfy internal and external standards
- 3Create streamlined business systems that identify and resolve quality problems
- 4Apply systematic problem solving to prioritize, communicate, and fix quality concerns
- 5Conduct experiments for process optimization and document findings
- 6Monitor CTQ parameters and specifications through process control
- 7Implement product and process improvement methodologies such as Six Sigma and Lean Manufacturing
- 8Investigate and prevent product and process non‑conformances
- 9Support quality disciplines as a core team member
- 10Complete risk analyses and collaborate with design engineering on verification and validation
- 11Ensure microbiology environmental monitoring aligns with product development activities
Requirements11
- 1Bachelor’s Degree in Engineering or related technical field
- 2Masters Degree Preferred
- 30‑2+ years of engineering experience using Quality tools and methodologies
- 4Detailed knowledge of FDA GMP ISO 13485 and ISO 14971 regulations
- 5Proven experience with medical device quality programs
- 6Familiarity with ASQ CQE certification preferred
- 7Ability to work in a matrixed and globally diverse environment
- 8Strong communication and leadership skills for cross‑functional teams
- 9Advanced computer skills including statistical analysis and report writing
- 10Prior experience with Six Sigma and Lean Manufacturing methodologies
- 11Experience in a broader enterprise or cross‑division business unit valued
Salary Insight
$51 - $101k per year
Location
Required Skills
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