Lead Quality Assurance Engineer

2 weeks ago

Irvine, California, United States Edwards Lifesciences Full time

About Edwards Lifesciences:
For over five decades, the Critical Care division at Edwards has been at the forefront of transformative medical advancements, dedicated to enhancing patient care.

Our Mission:
We are committed to ensuring that every patient who requires monitoring receives it through innovative technology.

Your Role:
If you are passionate about contributing your skills and dedication to the mission of Critical Care, we encourage you to consider this opportunity.

Joining our team means playing a vital role in elevating the standard of care and outcomes for countless patients globally.

Key Responsibilities:

  • Analyze intricate manufacturing quality and compliance challenges (e.g., CAPA, non-conformances, audit findings) for all production processes before final product release, utilizing engineering principles; assess results, provide recommendations, and prepare reports.
  • Identify and optimize complex manufacturing and/or R&D processes through engineering methodologies (e.g., Six Sigma and Lean techniques) for design for manufacturing and ongoing process enhancement.
  • Spot opportunities for redesigning basic equipment, tools, and fixtures to enhance manufacturing workflows and mitigate risks.
  • Develop, update, and sustain the technical content of risk management documentation for new product development and existing products.
  • Create training and documentation resources for production (e.g., work instructions) to facilitate seamless knowledge transfer regarding project and manufacturing processes.
  • Delegate support tasks; instruct technicians on testing procedures; mentor technicians and provide constructive feedback; and may oversee technician activities.
  • Guide and train junior employees on standard operating procedures.
  • Perform other incidental duties as assigned by leadership.

Qualifications (Required):
Bachelor's Degree in Engineering or a related field with a minimum of four years of relevant industry experience, or a Master's Degree or equivalent in Engineering or a related field with at least three years of relevant industry or educational experience.

Preferred Qualifications:
Demonstrated proficiency in MS Office Suite; experience with Minitab and CAD is advantageous.
Strong documentation, communication, and interpersonal skills, including negotiation and relationship management capabilities.
Familiarity with statistical methodologies and regulatory standards such as FDA, ISO 13485, and others.
Comprehensive understanding of engineering principles and risk management as per ISO 14971.
Excellent problem-solving, organizational, analytical, and critical thinking abilities.
Ability to manage competing priorities in a dynamic environment and work collaboratively within a team.

Compensation and Benefits:
We align our business objectives with performance, offering competitive salaries, performance-based incentives, and a comprehensive benefits package to meet the diverse needs of our employees and their families.

Commitment to Safety:
Edwards is dedicated to safeguarding our vulnerable patients and the healthcare professionals caring for them. Therefore, all patient-facing and in-hospital roles require COVID-19 vaccination, unless a medical or religious exemption is granted.

We are an Equal Opportunity/Affirmative Action employer, including protected Veterans and individuals with disabilities.

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