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Quality Systems Analyst

Job Type
Location
Plymouth, Minnesota
Salary
US$90000 - US$110000 per year + (Negotiable) + Full Benefits Package
Job Ref
BBBH2310391_1733513632
Date Added
December 6th, 2024
Consultant
tyler rostad

SRG, the leader in the Life Sciences human capital industry, is looking for a Quality Systems Analyst who will be responsible for the development and implementation of quality systems based on business, regulatory and customer requirements. Also provides training and consultation in various parts of the business and resolves procedural breakdowns.

JOB RESPONSIBILITIES include, but are not limited to:

  • Monitor and track alignment the clients Standards and any other quality system initiatives.
  • Ensures quality systems are effectively deployed.
  • Performs periodic checks to verify appropriate application.
  • Uses statistical methods, quality tools and computer-generated reports to continuously improve process capability. · Monitors and reports Quality Management System metrics.
  • Leads and participates in quality system improvement initiatives.
  • Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.

WHAT YOU NEED TO HAVE:

  • Bachelors Degree or equivalent experience
  • 1-3 years in Quality Systems
  • Experience in an FDA regulated industry

REQUIRED KNOWLEDGE, SKILLS, ABILITIES

  • Knowledge of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971.
  • Knowledge of Microsoft Office or Proficient in Microsoft Office
  • Ability to function independently as well as part of a team
  • Ability to manage multiple priorities in fast-paced environment
  • Good planning, multi-tasking, and project management skills
  • Demonstrated track record of completing projects on time and accomplishing goals
  • Ability to manage multiple priorities in fast-paced environment
  • ASQ Certification and/or Six Sigma training desired; Project Management/Excellence; Quality Systems and ISO regulations, software application knowledge preferred: EZDOC, EtQ, Compliance Wire, Siebel, Microsoft Professional Office Suite (MS Word, MS Excel, MS Outlook, MS Access)

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

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