Altran Innovative Product Development is a small company within a big company. About 150 US-based engineers working primarily in our Burlington, Massachusetts office, are deployed in small teams to accelerate the development of complex cloud-based software solutions and electro-mechanical products.
Altran provides a full complement of technology consulting, software and product development services to clients ranging from established startups to Fortune 500 companies. Currently, we are engaged in the development of next-generation semiconductor manufacturing systems, diabetes management solutions, automated warehouse robotic systems, clinical diagnostic systems, commercial-grade hot beverage dispensers, and clinical data management solutions, to name a few.
Dozens of teams of highly skilled Altran engineers participate in several new product introductions each year. 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. Each engineer has the opportunity to make highly visible and valuable contributions. Every project represents an opportunity to learn and grow as an engineer, and as a leader.
Altran North America is currently seeking a Senior Quality Assurance 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.
* Working with the Head of Quality Assurance, plan and implement process improvement initiatives.
* Work 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
* 5+ years of experience within a QA role, with a working knowledge of medical device regulated processes - e.g., 21 CFR 820
* Knowledge of relevant international standards - ISO 14971, IEC 62304, IEC 60601, ISO 270001
* Strong written and interpersonal communication skills
* Ability to manage competing priorities
* Ability to evaluate process tradeoffs
* Bachelor's Degree in a technical subject matter
* ASQ certification is a plus
Equal Opportunity/Affirmative Action Employer; M/F/D/V
Altran Technologies SA is a France-based company that specializes in the advanced engineering consulting and innovation consultancy.