Senior Quality Compliance Analyst Altran
Burlington, MA

Job Description

Company Overview

Altran Innovative Product Development (IPD) consists of around 150 US-based engineers working in small teams to develop a variety of complex systems in partnership with our clients.

Altran IPD focuses on the critical challenge of bringing products from concept to production-ready release, balancing speed and agility in delivery with an emphasis on creating reliable, supportable and extensible designs. Our engineers are not distracted by the ongoing and unpredictable demands of supporting existing products and instead are able to maintain a focus on driving the new development efforts. Thus, our teams move at a very rapid pace, delivering exciting results for our clients and maximizing the learning opportunities for our employees.

Altran provides a full complement of technology consulting, software and product development services to clients ranging from established startups to Fortune 500 companies, in industries such as medical devices, healthcare information systems, industrial automation, autonomous vehicles and capital equipment.

At Altran you will face a steady stream of new client challenges and work with a variety of talented coworkers, as you keep pace with the technological trends driving each generation of new products.

For more information, visit www.altran.com/us/en/

Job Description

Altran North America is currently seeking a Senior Quality Compliance Analyst in Burlington, Massachusetts. The Senior Quality Assurance Analyst participates in process improvement initiatives and provides direction within the organization through interactions with multi-discipline project teams, management, customers, and external auditors.

If you have a background in Quality and enjoy auditing and learning about engineering activities, please read on.

Responsibilities

* Work closely with the Head of Quality Assurance to plan and implement process improvement initiatives.
* Collaborate with project management and team members during the early stages of the project to establish plans, standards, and procedures to satisfy both the constraints of the project and the organization's policies.
* Review and audit the activities, work products, process evidence (i.e. records), and create the Quality Assurance Plan for client engagements and company functions to verify that they comply with the applicable procedures and standards.
* Participate in audits in support of ISO 9001 and ISO 13485 certifications.
* Develop and deliver QMS training
* Occasionally travel (up to 25%) to other Altran or client locations to assess/audit customer processes for software and hardware in scope for the project

Qualifications

*

Bachelor's Degree in a technical subject
* 5+ years of experience within a QA role
* Working knowledge of medical device regulated processes - e.g., 21 CFR 820
* Knowledge of relevant international standards - ISO 14971, IEC 62304, ISO 270001
* Strong written and interpersonal communication skills
* Ability to manage competing priorities
* Ability to evaluate process tradeoffs
* ASQ certification is a plus

Equal Opportunity/Affirmative Action Employer; M/F/D/V