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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 leading global organization specializing in medical device robotics and digital solutions.

This position offers a full-time role with comprehensive benefits. As a member of this team, you will have access to 50% paid medical and dental coverage, a 401K plan, and a variety of 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 organization is a global leader in surgical innovations, with products and solutions utilized in operating rooms worldwide. They have been at the forefront of surgical advancements for over a century, from developing the first sutures to pioneering minimally invasive techniques. Their commitment to addressing critical healthcare challenges and enhancing patient outcomes is evident through their diverse range of surgical technologies, including robotics, digital solutions, sutures, staplers, energy devices, and more.

Role Overview

The Senior Quality Engineer will play a crucial role in providing quality engineering support for manufacturing processes. The ideal candidate will possess experience with complex electro-mechanical and software-controlled systems tailored for medical applications. Collaboration with engineering teams is essential in this position. Knowledge 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 related standards.

Key Responsibilities

  • Establishes, modifies, and maintains quality standards and protocols for processing materials into finished products.
  • Works collaboratively 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 and specifies inspection and testing mechanisms; conducts quality assurance tests; performs statistical analyses to assess product non-conformance.
  • Ensures corrective actions meet reliability standards and that documentation complies with regulatory requirements.
  • May focus on areas such as design, incoming materials, production control, product evaluation, and research and development as they relate to quality.
  • Applies statistical methodologies for conformity assessment and improvement opportunities.
  • 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 resolve production and supplier issues.
  • Drives process improvement initiatives by capturing quality metrics and performing 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 observations in labs or manufacturing areas are 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 sector.
  • 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 capabilities.
  • Ability to work within a regulated environment, adhering to ISO 13485 and 21 CFR 820 standards.

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.