ERT

Senior Quality Process Engineer

Job Location US-PA-Philadelphia | US-PA-Pittsburgh | US-MA-Medford
Shift
Regular
Type
Regular Full-Time

Overview

ERT is looking to hire a Senior Quality Process Engineer. In this role you will work with the respective groups and departments at ERT to implement and estblish harmonized processes and tools across different locations and Business Lines. You will lead projects to establish, improve, maintain and train on Quality Management related tools and softwre solutions. You will have responsibility for establishing, updating and maintaining the ERT process flow chart. You will provide training on QA processes and lead Quality Management related integration activities in mergers and acquisitions.

Responsibilities

 

  1. Manage harmonization efforts for various ERT departments globally in defining, creating and changing process workflows among different locations. Mentoring, supporting and guideline departments and individuals on defining and documenting department processes capable to be integrated in an ERT process flow chart managed and maintained in ERT document Management System.

 

  1. Ensure process definitions made by the departments or individuals are in compliance with applicable standards and regulations.

 

  1. Provide suggestions on possible improvements to processes and harmonization efforts

 

  1. Support integration projects in ERT and proactively manages quality related topics in an integration project. Assures quality topics and requirements from GxP are considered in integration projects. Decide on Quality related issues in the harmonization projects and ensure compliance to GxP requirements.

 

  1. Lead QA projects or subprojects for implementation of software solutions and tools in ERT globally.

 

  1. Provides appropriate training to ERT staff on Quality Assurance processes. Supports line Managers in QA to develop training materials for QA processes. Implements methods for measuring training efficiency.

 

  1. Leads QA Process Harmonization projects, participates in ERT process harmonization or definition projects, and makes sure quality related issues (standards and regulations from ISO, FDA and GxP and best practice approaches) are considered in these projects.

 

  1. Ensures interactions of processes of the Quality Management System are available and regularly updates in ERT process flow chart.

 

  1. Establishes methods for monitoring and where appropriate measuring of Quality Management processes. Reports metrics for the process performance on a regular basis. Performs analysis the process metrics and make improvement suggestions to the QA line manager.

 

OTHER DUTIES AND RESPONSIBILITIES:

 

  1. Perform basic trainings on Process Management Tools and process flow chart for ERT departments and staff.
  2. Supports ERT Quality Management team in audits or assessments from clients and authorities.
  3. Supports ERT Quality Management team in implementing ISO certification processes in different ERT locations.
  4. Evaluates process deviations in ERT document Management System and identify any areas for improvements in ERT processes.
  5. Manages and maintains a process reference table to relevant ISO clauses for ERT locations.

  

 

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

Qualifications

Education:

 

  • Master or Bachelor Degree in a technical area or equivalent experience in Quality Management / Assurance or Process Management.

 

Experience:

 

  • Required at least 5 years of experience in Quality Management in Pharmaceutical / Medical environment
  • At least 3 years of experience in implementing and managing QM harmonization projects
  • 2 years acting as Project Manager in global projects
  • 2 years working experience of ISO and/or GCP related risk management activities and risk mitigation strategies
  • Excellent knowledge in Quality Management System (ISO9001 / ISO 13485 / ISO 27001) setup and implementation
  • Preferred 2 years of experience in managing change projects within an organization
  • Preferred 5 years of experience in either Lean, Six Sigma, Poka Yoke, Ishikawa, FMEA or other process analysis methods
  • Ability and desire to coach and train other staff members in ERT
  • Experience and knowledge about regulatory requirements (cGxP) especially in ISO, FDA and ICH related requirements   
  • Experience and knowledge in managing and supporting process changes desirable.
  • Experience working in a global team and international environment desirable.
  • Good skills in English language - Fluent in written and speaking. Secondary language (preferred German) desirable.
  • Excellent organizational and communication skills.
  • Willing to travel international
  • Excellent presentation skills

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

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