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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 medical device sector. This client is recognized globally for its innovative contributions to surgical solutions.

This role is 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 personal/sick leave. All employees receive annual performance evaluations.

About the Client: The client is a leader in surgical technology, providing essential products and solutions utilized in operating rooms worldwide. Their legacy spans over a century, having pioneered advancements from sutures to minimally invasive surgical techniques. Their commitment to improving healthcare and saving lives is evident through their innovative surgical technologies, including robotics, digital solutions, and energy devices.

Position Overview

The Senior Quality Engineer will play a critical role in delivering quality engineering support for manufacturing processes. The ideal candidate will possess experience with complex electro-mechanical and software-controlled systems in medical applications. This position involves collaboration with various engineering teams within the organization.

Key Responsibilities

  • Establishes, modifies, and maintains quality standards and protocols for the processing of materials into finished products.
  • Works closely with engineering and manufacturing teams to ensure adherence to quality standards.
  • Develops and implements inspection, testing, and evaluation methods to assess product precision and accuracy.
  • Designs or specifies testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analyses to evaluate product compliance.
  • Ensures corrective actions meet reliability standards and that documentation complies with regulatory requirements.
  • May focus on specific areas such as design, incoming materials, production control, and product evaluation.
  • 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 address 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.
  • This position operates in a professional office environment, utilizing standard office equipment.
  • Regular attendance at meetings and observations 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 abilities.
  • Ability to work within a regulated environment in compliance with ISO 13485 and 21 CFR 820.

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.