Cretex Medical Component and Device Technologies - Brooklyn Park, MN

posted 4 months ago

Full-time - Mid Level
Brooklyn Park, MN

About the position

The Senior Quality Engineer - Molding & Assembly at Cretex Medical plays a crucial role in ensuring quality assurance within manufacturing processes. This position focuses on developing and maintaining quality-related practices, providing technical guidance, and ensuring compliance with industry standards such as ISO 13485. The role emphasizes continuous improvement, leadership, and mentorship within the quality assurance team, while also collaborating with cross-functional teams to enhance product quality.

Responsibilities

  • Lead the creation and maintenance of process flow, control plans, inspection requirements, PFMEA's, and Master Validation Plans for production processes.
  • Act as the primary quality liaison with customers, addressing complaints through failure analysis and corrective actions.
  • Collaborate with programming and inspection teams to develop robust inspection programs and analysis processes.
  • Demonstrate expertise in device assembly and injection molding plastics to reduce process variation.
  • Provide support for IQ/OQ/PQ validation of Injection Molding tools and processes.
  • Establish and evolve quality standards and processes to ensure top-tier product delivery.
  • Identify areas for process improvement and drive lean initiatives for operational excellence.
  • Provide technical expertise in quality assurance to meet industry standards and regulations.
  • Conduct comprehensive quality audits and evaluate compliance against established standards.
  • Analyze quality data to detect trends and make informed recommendations.
  • Lead investigations into quality issues using CAPA methods and orchestrate corrective actions.
  • Establish and monitor key performance indicators (KPIs) for quality objectives.
  • Provide leadership in quality initiatives and foster a culture of excellence.
  • Collaborate with suppliers to ensure quality of incoming materials and conduct supplier audits.
  • Stay updated on industry regulations and ensure compliance with ISO 13485 and CFR 820.
  • Maintain meticulous documentation related to quality assurance processes.

Requirements

  • Bachelor's or Master's degree in an engineering or related field.
  • Minimum of 10 years of experience in quality engineering with progressively increasing responsibilities.
  • Demonstrated leadership skills to guide and inspire teams.
  • Proficiency in quality management systems and ERP tools.
  • Strong analytical skills to identify data patterns and trends.
  • Exceptional communication and interpersonal skills for collaboration.
  • Understanding of industry-specific quality standards, particularly ISO 13485.
  • Adaptability to excel in a fast-paced team environment.
  • Proficiency in Microsoft Office applications.
  • Certification in quality management, such as ASQ Certified Quality Engineer, is a valuable asset.

Nice-to-haves

  • Keen eye for detail and exceptional organizational skills.
  • Strong problem-solving and critical thinking abilities.
  • Leadership qualities to influence and drive change.
  • Outstanding organizational and project management skills.
  • Dedication to continuous improvement principles.
  • Participation in continuing education related to the field.

Benefits

  • Competitive wages
  • Rich benefit package
  • Positive work environment
  • Focus on continuous improvement
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