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Lead Quality Assurance Engineer

2 months ago

California, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science, Engineering, Technology, and Telecom, a managed solution provider and business unit of Kelly Services, is currently seeking a Senior Quality Engineer for a long-term engagement with a prominent client in the Global Medical Device Robotics & Digital Solutions sector. This organization is recognized as a leader in surgical innovations, with products utilized in numerous operating rooms worldwide.

This role offers a full-time position with comprehensive benefits. As a member of this team, you will have access to 50% paid Medical & Dental coverage, a 401K plan, and various other benefits. Additionally, you will be entitled to paid time off, including holidays, vacation, and sick/personal days. All employees receive annual performance evaluations.

About the Company

The Robotics & Digital Solutions division is part of a global leader in surgical technology, contributing to advancements in surgery for over a century. Their commitment to innovation is focused on addressing critical healthcare challenges and enhancing patient outcomes through advanced surgical technologies, including robotics, digital solutions, and various medical devices.

Role Overview

The Senior Quality Engineer will provide essential quality engineering support for manufacturing processes. The ideal candidate will possess experience with complex electro-mechanical and software-controlled systems within the medical field. This role involves collaboration with engineering teams to ensure compliance with medical device regulatory standards.

Key Responsibilities

  • Establishes, modifies, and maintains quality standards and protocols for material processing.
  • Works alongside engineering and manufacturing teams to uphold quality standards.
  • Develops and implements inspection and testing methods to evaluate product precision and accuracy.
  • Designs inspection mechanisms and conducts quality assurance tests, performing statistical analyses to identify product discrepancies.
  • Ensures corrective actions align with reliability standards and that documentation meets compliance requirements.
  • May focus on specific areas such as design, incoming materials, production control, or product evaluation.
  • Applies statistical methodologies for conformity assessment and quality improvement initiatives.
  • Reviews equipment and process validations to ensure compliance and assess product reliability.
  • Approves test method validation and stability plans.
  • Leads teams in corrective and preventive actions to resolve production and supplier issues.
  • Drives process improvement by capturing quality metrics and conducting analyses to enhance product design.
  • Develops product quality plans and specifications in collaboration with product development teams.
  • This position operates in a professional office environment, utilizing standard office equipment.
  • Regular attendance at meetings and observation in labs or manufacturing areas is required.
  • Occasional evening and weekend work may be necessary based on job demands.

Qualifications

Required:

  • Bachelor's degree in Science, Engineering, or a related field.
  • A minimum of 5 years of quality engineering experience in the medical device industry.
  • Experience with complex electro-mechanical and software-controlled systems.
  • Familiarity with pFMEAs, Test Method Validations, Root Cause Analysis, CAPAs, and Process Validations.
  • Strong analytical and problem-solving skills.
  • Ability to work in a regulated environment, adhering to ISO 13485 and 21 CFR 820 standards.

Important Information: This position is recruited for by a remote Kelly office. Applicants must be legally authorized to work in the United States without employer sponsorship.