QA Engineer II Job
Expiry Date :
Fri, 06 Nov 2020 23:59:59 GMT
Apply Job :
Date: Oct 2, 2020
Location: Marlborough, MA, US, 01752
Company: Boston Scientific
Purpose and Passion
– Comprehensive Benefits
– Life-Work Integration
– Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work.
QA Engineer II
About This Role:
Serves as a QA Engineer II supporting global post market operations with a primary focus on Intelligent Automation (IA) via Robotic Process Automation (RPA). This role requires strong business process analysis and quality system documentation skills to drive and manage the implementation of IA to improve the quality and productivity of post market tasks and deliverables. This role provides opportunity to further develop experience and expertise in the following areas supported by this team.
* Vigilance Reporting (BSI, DEKRA, Periodic Summary and Worldwide Reporting)
* Data and Management Review
* Acquisition and Divestiture
* CAPA & NCEP
* Special Projects
Your Responsibilities Will Include:
* Providing project management, business process analysis and quality system documentation, e.g. Global System Methodology (GSM) deliverables to implement RPA/Bot Projects.
* Improving quality and productivity of the organization by defining, developing and/or validating post market data or processes used to address automation requirements.
* Establishing and maintaining processes and quality records generated to address requirements.
* ing sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
* Leading departmental or cross-functional initiatives (VIPs or new requirements) for IA to ensure post market process automation and implementation requirements are addressed
* Driving alignment and best practice across all post market sites and functions using IA.
* Ability to effectively gather detailed business requirements for automation and effectively communicate requirements to RPA developers.
* Ability to identify and escalate risk and effectively resolve issues.
* Ability to coordinate parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders to manage IA projects from concept to implementation and post-production support.
* Ability to formally define and establish processes to managing IA workload and issues effectively using JIRA (and agile process).
* Ability to effectively complete all required GSM deliverables, including documentation, to ensure validation of IA for implementation.
What We’re Looking For In You:
* Bachelor’s Degree in the Engineering or Science field with 3-5 years of related experience or an equivalent combination of education and work experience.
* Comprehensive understanding of quality system requirements from US and International regulations and standards applicable to Medical Devices, including 21 CFR 803 & 820, ISO 13485:2016
* Strong analytical skills and working knowledge of Trackwise and/or SAS applications
* Demonstrated quality system documentation skills, including quality records (e.g. complaints, investigations, vigilance reports), Project Tracking Plans, Complaint Management Plans, SOPs, WIs or templates.
* Strong communication skills (written and verbal), e.g. comfortable speaking and presenting to different levels of management and cross-functional stakeholders.
* Lean Business Process/DMAIC/Kaizen Experience/Process Mapping
* Experience with documenting GSM deliverables (e.g. validation documents, GSM Assessments, Small Project Documents)
* Project Management
* Experience with Post Market systems / processes
* Experience working with technical, i.e. IT and developer resources
* Flexible and positive attitude; self-starting
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Nearest Major Market: Boston
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