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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 within a prominent client in the Global Medical Device Robotics & Digital Solutions sector. This client is recognized as a leader in surgical innovations, with products utilized in numerous operating rooms globally.

This position is a full-time role with comprehensive benefits. As a member of this team, you will have access to 50% paid Medical & Dental coverage, a 401K plan, and a variety of additional benefits. Paid time off is also included, covering holidays, vacations, and personal/sick days. All employees receive annual performance evaluations.

Robotics & Digital Solutions is a division of a global leader in surgical technology, with a legacy of over a century in advancing surgical practices. Their commitment to shaping the future of surgery is driven by a dedication to addressing critical healthcare challenges and enhancing patient outcomes. Their portfolio includes surgical technologies such as robotics, digital solutions, sutures, staplers, energy devices, and more, aimed at treating serious medical conditions worldwide.

Position Overview

The Senior Quality Engineer will play a crucial role in delivering quality engineering support for manufacturing processes. The ideal candidate will possess experience with complex electro-mechanical and software-controlled systems within medical applications. Collaboration with engineering teams is essential for this role. A strong understanding of the medical device regulatory landscape (FDA, MDD, ISO) is required, along with expertise in Design for Reliability and Manufacturability (DRM), Design for Six Sigma, and risk management in accordance with ISO 14971 and other relevant standards.

Key Responsibilities

  • Establishes, modifies, and maintains quality standards and protocols for processing materials into finished products.
  • Works closely with engineering and manufacturing teams to ensure adherence to quality standards.
  • Develops and implements methods for inspecting, testing, and evaluating product precision and accuracy.
  • Designs or specifies inspection and testing mechanisms; conducts quality assurance tests; performs statistical analyses to evaluate product compliance.
  • Ensures corrective actions meet reliability standards and that documentation complies with regulatory requirements.
  • May focus on design, incoming materials, production control, product evaluation, and reliability as they relate to quality.
  • Applies statistical methodologies for conformity assessment and to identify opportunities for quality system improvements.
  • Reviews equipment and process validations to ensure compliance and assess impacts on product reliability.
  • Approves test method validation and stability plans and reports.
  • Leads or participates in corrective/preventive action teams to address production and supplier issues.
  • Drives process improvement initiatives by capturing quality metrics and conducting analyses to enhance product design.
  • Develops product quality plans and specifications in collaboration with product development teams, including risk analyses and FMEAs.
  • This role operates in a professional office environment, utilizing standard office equipment.
  • Regular attendance at meetings and observation in labs or manufacturing areas is required. Frequent sitting, standing, or walking may be necessary.
  • Occasional evening and weekend work may be required 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 for medical applications.
  • Familiarity with pFMEAs, Test Method Validations, Root Cause Analysis, CAPAs, and Process Validations.
  • Strong analytical and problem-solving abilities.
  • Ability to work within a regulated environment, ensuring compliance with ISO 13485 and 21 CFR 820.

Important Information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally authorized to work in the United States without employer sponsorship.