Jump to navigation

Thank You For Signing Up!

We will be launching updates to VentureFizz soon which will include a new profile page and a custom homepage. We will keep you posted on these updates - stay tuned! Continue
VentureFizz Logo
Menu
  • Sign Up
  • Login
  • Cities
    • Boston
    • New York
    • All
  • Companies
    • AdTech
    • Big Data & Analytics
    • Communications
    • Consumer
    • Development & Interactive Agencies
    • eCommerce & Marketplaces
    • EdTech
    • Energy & CleanTech
    • Enterprise Software / SaaS
    • FinTech & Payments
    • Gaming
    • Hardware & Robotics
    • Healthcare & Pharma
    • Infrastructure & Storage
    • IoT
    • Marketing & Sales Tech
    • Other
    • Security
    • Venture Capital
  • Job Board
    • Analytics & Data Science
    • Customer Success
    • Hardware Engineering
    • HR, Finance, & Operations
    • IT/Systems/Networking
    • Marketing
    • Other
    • Product Management
    • Sales & Business Development
    • Software Engineering/QA
    • UX & Design
  • Insights
  • Videos

Quality Process Engineer

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.


Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to 

 

 

ERT is hiring a Quality Process Engineer. You will work with respective groups and departments at ERT to implement and establish harmonized processes and tools among different locations. You will have responsibility for establishing, updating, and maintainig the ERT process flow chart. You will also provide training on the Qualit Assurance processes.

Responsibilities

  1. Supports ERT departments in defining, creating and changing process workflows among different locations. Mentoring of 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. Participates in 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.

 

  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 and 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

  1. Master or Bachelor Degree or equivalent experience in Quality Management / Assurance or Process Management.
  2. Required at least 3 years of experience in Quality Management or Pharmaceutical / Medical environment
  3. Preferred 2 years experience in either Lean, Six Sigma, Poka Yoke, Ishikawa, FMEA or other process analysis methods
  4. Ability and desire to coach and train other staff members in ERT
  5. Experience and knowledge about regulatory requirements (cGxP) especially in ISO, FDA and ICH related requirements   
  6. Experience and knowledge in managing and supporting process changes desirable.
  7. Experience working in a global team and international environment desirable.
  8. Good skills in English language - Fluent in written and speaking. Secondary language (preferred German) desirable.
  9. Excellent organizational and communication 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. 

More Jobs at ERT

Clear Filters
Quality Process Engineer
Philadelphia
Software Engineering/QA
Details
Manager, Security & Risk Management
Philadelphia
IT/Systems/Networking
Details
Team Leader, Translations
Philadelphia
HR, Finance, & Operations
Details
Representative - Customer Care (Technical Help Desk)
Philadelphia
Customer Success
Details
Data Privacy Engineer
Philadelphia
Software Engineering/QA
Details
Project Manager II
Philadelphia
HR, Finance, & Operations
Details
Project Manager - eCOA Clinical Trials
Philadelphia
HR, Finance, & Operations
Details
Project Manager II
Philadelphia
HR, Finance, & Operations
Details
Senior Project Manager
Philadelphia
HR, Finance, & Operations
Details
Customer Care Helpdesk Supervisor
Philadelphia
Customer Success
Details
Translations Project Manager
Philadelphia
HR, Finance, & Operations
Details
Senior Director Technology Services and Operations
Philadelphia
IT/Systems/Networking
Details
Manager, Proposal Operations
Philadelphia
HR, Finance, & Operations
Details
Intern (Marketing Communications)
Philadelphia
Marketing
Details
Sr. HR Business Partner
Philadelphia
HR, Finance, & Operations
Details
Director, Strategic HR Business Partner
Philadelphia
HR, Finance, & Operations
Details
Project Manager
Philadelphia
HR, Finance, & Operations
Details
Security Analyst
Boston
IT/Systems/Networking
Details
Manager, Security & Risk Management
Boston
IT/Systems/Networking
Details
Team Leader, Translations
Boston
HR, Finance, & Operations
Details
Data Privacy Engineer
Boston
Software Engineering/QA
Details
Director, Global Category Management
Boston
HR, Finance, & Operations
Details
VP, Product Management
Boston
Product Management
Details
Data Manager
Boston
Analytics & Data Science
Details
Executive Assistant
Boston
HR, Finance, & Operations
Details
Project Manager
Boston
HR, Finance, & Operations
Details
Project Manager - eCOA Clinical Trials
Boston
HR, Finance, & Operations
Details
Project Manager II
Boston
HR, Finance, & Operations
Details
Senior Project Manager
Boston
HR, Finance, & Operations
Details
Senior Director Technology Services and Operations
Boston
IT/Systems/Networking
Details
Manager, Proposal Operations
Boston
HR, Finance, & Operations
Details
Showing 31 Jobs

ERT

Add to Favorites

ERT is a global data & technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence.

Apply Now
Company Profile

Number of Employees

1,000+ Employees

Open Positions

31

Videos

Photos

ERT Company Photos
ERT Company Photos
ERT Company Photos
ERT Company Photos

Employee Testimonials

“Working at ERT is inspiring because it helps me grow intellectually and in my career. I’m passionate about working here because I get a chance to work on delivering life-changing medicines that help people live healthier and better lives.”

Udit   –   Software Engineer, Boston

“I love to work at ERT, and every day, I’m motivated. I feel appreciated and valued, and I definitely have the chance to grow and show who I am.”

Romina   –   Senior Project Manager, Estenfeld Germany

“What I appreciate the most are the opportunities that we have for career growth and learning. I started here seven years ago, and I’ve been able to move through three positions. There’s always opportunity to work on new and interesting things!”

Jason   –   Project Management, Philadelphia

“The culture at ERT is one of enabling success. We put a lot of effort and attention into our people because they’re our most valuable resource. I appreciate the investment back in me.”

Kelsey   –   Cardiac Safety Solutions, Philadelphia

“What makes ERT a great place to work is the companionship and working together, the friendships you develop. It’s been one of the greatest experiences in my life. I can’t wait to come to work in the morning — I’ve been here eight years and I haven’t missed a day!”

Andrew   –   Inventory Control Supervisor, Boston

“Working at ERT is interesting, because you’re always challenged. If you want to constantly grow, constantly learn new things, constantly expand your knowledge base and your skill sets, then this is the place to be.”

Bryan   –   Education & Training, Philadelphia

Copyright © 2015-2020 VentureFizz. All rights reserved.

  • About
  • Member Login
  • Contact
  • Terms of Service
  • Privacy Policy
  • Cities
      • Boston
      • New York
      • All
  • Companies
      • AdTech
      • Big Data & Analytics
      • Communications
      • Consumer
      • Development & Interactive Agencies
      • eCommerce & Marketplaces
      • EdTech
      • Energy & CleanTech
      • Enterprise Software / SaaS
      • FinTech & Payments
      • Gaming
      • Hardware & Robotics
      • Healthcare & Pharma
      • Infrastructure & Storage
      • IoT
      • Marketing & Sales Tech
      • Other
      • Security
      • Venture Capital
  • Jobs
      • Analytics & Data Science
      • Customer Success
      • Hardware Engineering
      • HR, Finance, & Operations
      • IT/Systems/Networking
      • Marketing
      • Other
      • Product Management
      • Sales & Business Development
      • Software Engineering/QA
      • UX & Design
  • Insights
    • CxO Briefing
    • Inside:
    • Black in Tech
    • Office Tours
    • The VentureFizz Podcast
    • Lead(H)er
    • Engineering Spotlight
    • Working in Tech
    • Career Path
    • Hottest Jobs in Tech
    • Talent on the Move
  • Videos
    • <p><a href="/videos">Videos</a></p>