Quality Assurance Manager

Elitechgroup, Inc. Bothell , WA 98021

Posted 2 weeks ago

The ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies that offer innovative products and solutions, ELITechGroup has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient.

The ELITechGroup manufactures and distributes diagnostic products for clinical chemistry, microbiology, immunology, and molecular biology though direct sales and a distribution network encompassing more than 100 countries.

Summary

With direction, has part of the responsibility for ELITechGroup Molecular Diagnostics' quality assurance activities.

Essential Duties and Responsibilities

  • Collects and organizes data that measure the effectiveness of the QMS

  • Manages quality records for Epoch.

  • Manages internal audit system for Epoch.

  • Performs audits of company areas and processes to confirm compliance with controlled procedures

  • Coordinates the customer complaint system.

  • Develops and implements key quality system processes to ensure compliance with all relevant regulatory requirements.

  • Manages product development projects as assigned by supervisor.

  • Coordinates and/or develops and performs quality system and quality assurance training.

  • As the only standing member of the Change Review Board, assesses all changes to documents and processes.

  • Provides guidance for responses to CAPAs and NCRs.

  • Provides support for the quality system during corporate and third party audits.

  • Manages site-specific regulatory activities.

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Initiative works independently will little or no supervision; takes independent actions and calculated risks; asks for and offers help when needed.

Interpersonal Skills - focuses on solving conflict; maintains confidentiality; listens to others without interrupting; remains open to others' ideas and tries new things.

Judgment - ability to work independently; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions.

Organizational Support - follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values.

Problem Solving - identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topics.

Project Management - coordinates projects; communicates changes and progress; completes projects on time and budget.

Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.

Written Communication - writes clearly and informatively; able to read and interpret written information.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Bachelor's degree (B.A. or B.S.) or higher from four-year college or university; and at least three years related experience and/or training; or equivalent combination of education and experience.

  • Internal quality auditor qualification required.

  • Prior responsibility for quality system development and maintenance in in vitro diagnostics

  • Prior experience with manufacturing operations.

  • Experience with Quality System Documentation and good documentation practices.

  • Detailed knowledge of ISO 13485, ISO 9001, FDA QSR, IVDD and cGMP.

Work Environment

While performing the duties of this job, the employee is not exposed to environmental conditions. The noise level in the work environment is usually moderate.


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