ERT

Quality Engineer (Regulatory Affairs)

US-MA-Boston
Shift
Full time/Regular
Type
Regular Full-Time

Overview

ABOUT ERT

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it 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. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedInTwitter, and Facebook.

 

Join us! ERT is looking for a Quality Engineer to partner with cross-functional groups and departments involved in the development and implementation of products, all working together to ensure delivery of high quality, reliable, auditable, and regulatory compliant products and solutions. This role truly leads to Confidence at Every Turn!

 

Responsibilities

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. Ensures business and compliance requirements for ERT proprietary products/solutions are considered and directly maintained by the Platform, Development, Verification and Validation and supporting departments in accordance with the Product Lifecycle and Development Lifecycles.
  1. Performs continuous evaluation of documentation and processes associated with products/solutions (i.e. proprietary hardware/software and client specific deployments) under definition, development and test.
  1. Reviews requirements, specifications and technical design documents to provide timely and meaningful feedback with the expectation of enhancing product efficiency.
  1. Supports development team members during the Product Life Cycle and Development Life Cycle to ensure high quality, requirements resulting in reliable and safe products and solutions. Works closely with the product, project, development and readiness teams to help facilitate successful product/solution implementation.
  1. Serves as the primary point of contact for quality issues during development and ensures routine communication of quality issues to Project, Product, Development teams and line manager.
  1. Serve as a Quality Subject Matter Expert in design and change process for the related product or solution. Give guidance to and support other team members in the Product, Project and Development Teams on quality related issues.

 

OTHER DUTIES AND RESPONSIBILITIES:

 

  1. Interfaces with testing, operational readiness, regulatory and purchasing teams to implement the product and solution as agreed in the product / platform team.
  2. On an individual project basis, deconstructs the development processes into goals such as verifications, activities, measurements, abilities, and commitments. Identifies process improvements, error trends, and/or the root causes.
  3. Supports the identification and evaluation of risks related to the product and solution
  4. Supports the product / platform team in managing customer expectations and usability issues
  5. Decides on deviations / modifications for the product / platform according to existing ERT SOPs.
  6. Documents quality and performance related metrics for the product or solution to identify improvement tasks for the different phases of the Product Life Cycle.    

 

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

QUALIFICATIONS AND SKILLS NEEDED: 

 

  1. Master or Bachelor Degree or equivalent experience in Quality Management / Assurance or Software Engineering required.
  2. Required at least 5 years of experience in SW project teams with a strong focus on SW quality.
  3. Ability and desire to coach other staff members in software and hardware development teams.
  4. Good experience and knowledge about regulatory requirements (cGxP) in Software and Hardware development projects according to ISO, FDA and ICH related requirements
  5. Required at least 2 years experience in Agile development methodology and documentation requirements to ensure compliance to international standards and regulations for medical and non-medical products.
  6. Knowledge of maintaining electronic documents and records in a high regulated work environment (e.g. pharmaceutical drug development or medical device manufacturing) preferred.
  7. Experience working in a global team and international environment desirable.
  8. 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. 

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