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Kelly Services Quality Assurance and Regulatory Affairs Specialist in Eugene, Oregon

Kelly Science & Clinical is excited to be hiring a Quality Assurance and Regulatory Affairs Specialist in Eugene, OR for an exciting and innovative company revolutionizing feminine care products! The QA Regulatory Specialist is responsible for management of quality and regulatory system. Specifically, the position develops, maintains and enforces quality assurance standards while always leaning into continuous improvement.

Responsibilities:

  • Manages, Implements, and develops quality system procedures to ensure that all medical device products meet required specifications for FDA and GMP requirements.

  • Assists with internal audits

  • Ensure product compliance with GMP, ISO 9001 & ISO 13485

  • Design, implement, improve, and maintain the document control system

  • Create documents for change orders and other activities required

  • Gather, analyze and present data from multiple sources and across various formats to provide tracking of product testing

  • Maintains and updates all product documentation with appropriate quality parameters for all existing and new products.

  • Communicates quality standards and assists other company personnel as requested

  • Coordinates product testing processes and maintains records.

  • Identifies and analyzes issues, defects, and other problems, particularly when problems reoccur in multiple products; recommends and facilitates solutions to these issues.

  • Reviews client, customer, and user feedback.

Requirements:

  • Bachelors degree in Science related field, Engineering, or field related to the medical products industry required

  • Three to five years of meaningful work experience in quality management required

  • Must have validated experience working in an ISO and GMP regulated environment, particularly with ISO 9001 and 13485.

  • Ability to take initiative, plan, and execute tasks independently

  • Ability to balance attention to detail and swift execution

  • Must be flexible to work onsite 30-50% of the time with flexibility for remote work hybrid.

Perks:

Our client offers a full benefit package including health, dental and vision insurance, profit sharing and supported 401K plan. Paid holidays and 80 hours of PTO

Interested Candidates:

  • Apply for Immediate Consideration

  • Schedule and interview with Athena https://calendly.com/athp320/interview

  • Text Start to Athena at 714-868-5477 with any questions. Please be sure to include which job you are interested in.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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