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Actalent Quality Engineer - Risk Management in Mesa, Arizona

Description:

seeking a highly skilled and detail-oriented Quality Engineer with a strong focus on risk management to join our dynamic team. The successful candidate will play a critical role in ensuring the quality and safety of our specialty lenses through effective risk management practices

  • Develop, implement, and maintain risk management processes in accordance with industry standards and regulatory requirements.

  • Conduct risk assessments and hazard analyses to identify potential risks associated with product design, manufacturing processes, and supply chain operations.

  • Collaborate with cross-functional teams to develop and implement risk mitigation strategies.

  • Monitor and evaluate the effectiveness of risk management activities and make recommendations for continuous improvement.

  • Ensure compliance with quality standards, including ISO 13485 and FDA regulations.

  • Lead root cause analysis and corrective action processes for quality issues.

  • Prepare and present risk management reports to management.

  • Participate in internal and external audits related to risk management and quality assurance.

  • Provide training and support to team members on risk management principles and practices

Additional Skills & Qualifications:

  • Minimum of 3-5 years of experience in quality engineering, with a focus on risk management in a manufacturing environment

  • 2+ years Experience with ISO 13485 and FDA regulations within medical device industry

  • must be able to travel internationally for 1-2 weeks at a time up to 50% of the time

Requirements:

  • Travel will be required (international to Europe 50% of the time)

  • Must have a Engineering degree

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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