Junior Quality Assurnace

Altran US Burlington, MA
Company Overview

Today's complex interconnected world demands companies to conceptualize and deliver cutting-edge products and solutions to market faster than ever before. Altran, a global product development partner, collaborates with companies to address the business and technical challenges inherent in developing and supporting complex connected systems.

For over three decades, leading companies and emerging startups in some of the most highly regulated and rapidly evolving industries have relied on Altran to inspire innovation, accelerate time to market, improve predictability, and maximize return on product investment. Altran provides a full complement of technology consulting, software and product development expertise, and engineering services to our client partners in the Aerospace, Automotive, Energy, Industry and Electronics, and Medical and Life Sciences industries.

In North America, Altran is based in Burlington, Massachusetts, with additional offices in Atlanta, Chicago, Detroit, New Jersey, Silicon Valley and Southern California. For more information, visit altran-na.com.

Job Description

Altran is looking for a Junior Quality Assurance Engineer to work onsite with the Andover, MA.

Responsibilities

Description: Evaluate, investigate, track and complete complaints through effective and established complaint handling processes.

* Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.

* Participate and collaborate objectively with productive conclusions in the Complaint Handling Unit meetings.

* Coordinate with the reportable complaint investigators in providing any missing information for root cause activities.

* Collaborate with Engineering, Customer Support, Field personnel, Market Service Order reviewers and other appropriate groups for adequate initial evaluation of complaints.

* Collaborate with Adverse Event Coordinators for reportable complaints as well as Product Safety Committees for Correction and Removal process.

* Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data gets pushed to the appropriate departments for actions.

* Support reviews and audits assigned.

* Work with the Post Market Surveillance Manager for any other projects assigned.

Qualifications

* 3+ years of experience in a medically regulated and technical environment in (FDA Class I or II equivalent – Class III a plus).

* Bachelor Degree or higher in scientific, health care, nursing or related field, or relevant years' work experience.

* Demonstrated strong results orientation.

* Proficiency using statistical tools such as Tableau, Minitab, and various other computer software applications.

* Proficiency using office tools such as Microsoft Access and Excel, ClearQuest, and various other computer software applications.

* Must be able to work under pressure to meet regulatory reporting time frames and company requirements.

* Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.

* Requires the proven ability to consistently meet and/or exceed goals. Must be capable of making commitments, setting priorities, and delivering results on time and on budget. Effective team building skills.

* Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.

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