Job Description

Watson Health- Senior QMS Quality Engineer

* Country:US
* State:WISCONSIN
* City:Hartland
* Category:Software Development & Support
* Required Education:Bachelor's Degree
* Position Type:Professional
* Employment Type:Full-Time
* Contract Type:Regular
* Company:(0147) International Business Machines Corporation
* Req ID:347807BR
* Travel Required:Up to 10% or 1 day a week
* Min Salary:
* Max Salary:
* Currency:
* Location:Hartland, WI US

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Introduction
At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most challenging problems? If so, lets talk.

Your Role and Responsibilities
As the Senior QMS Project Manager or Senior QMS Quality Engineer and member of the Watson Health RAQA organization you will support the Quality Management System, including: Corrective Action/Preventative Action (CAPA), complaints and premarket release and post market surveillance processes. You will use your knowledge of global Medical Device regulations and standards to support post market surveillance processes for Watson Health. This will include participation in design control activities, CAPA resolution, complaint investigations, recall activities and production/process controls which includes further refinement and development of QMS processes. You will interface with the business and functional leaders in development, offering management, fulfillment, solution teams, regulatory, legal and other stakeholders to promote and support QMS compliance.

Essential Job Duties

* Works under minimal supervision and in conjunction with team members to develop, implement, maintain, and improve the quality management system to ensure that the quality system is established and maintained in accordance with the applicable regulations in USA, Canada, Brazil, Japan, EU, UK, Australia and Singapore at a minimum.
* Participates in the internal and external audit program to assure ongoing compliance. Conducts audits as lead and/or supporting auditor per the audit schedule.
* Works with cross functional team members to investigate and propose solutions to identified issues from the (CAPA) process. Tracks CAPA investigations through completion to ensure identified nonconformances are corrected and recurrence prevented.
* Recognizes complex problems related to project objectives and applies sound judgement when addressing the issues.
* Independently generates solutions based on analytical skills and business knowledge.
* Analyzes situations and proposes solutions to QMS and business needs by developing/modifying QMS procedures and processes.
* Participates in FDA and other regulatory and QMS inspections.
* Support implementation and management of systems and tools for Document/Record Management, CAPA, complaint handling and post market surveillance processes.
* Apply Continuous Improvement methodologies to compliance processes, tooling and workflows.
* Pursues a program of self-development through the use of selected reading, seminars, and participation in continuing education.
* Generates quality metrics and reports for Management Reviews at prescribed intervals.
* Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures.
* Assists in creating and implementing procedures in the Quality Management System
* Identifies and communicates possible improvements in the work process for customers and peers.
* Performs other duties as assigned by immediate supervisor or upper management

Required Technical and Professional Expertise
* BA/BS in a scientific discipline including a minimum of 5 years in the medical industry and a minimum of 2 years in a QA or RA role for a medical device company which included quality system audit experience.
* Understands and implements the quality system in accordance with USA, Canada, Brazil, Japan, EU, UK, Australia and Singapore requirements.
* Excellent interpersonal, communication, and negotiation skills
* Familiar with database entries and queries

Preferred Technical and Professional Expertise
n/a

About Business Unit
IBMs Cloud and Cognitive software business is committed to bringing the power of IBMs Cloud and Watson/AI technologies to life for our clients and ecosystem partners around the world. IBM provides you with the most comprehensive and consistent approach to development, security and operations across hybrid environmentswith complete software solutions for business and IT operations, development, data science, security, and management. Our experts and software capabilities help organizations develop applications once and deploy them anywhere, integrate security across the breadth of their IT estate, and automate operations with management visibility. With IBM, you also have access to new skills and methods, governance and management approaches, and a deep ecosystem of industry experts and partners.

Your Life @ IBM
What matters to you when youre looking for your next career challenge?

Maybe you want to get involved in work that really changes the world? What about somewhere with incredible and diverse career and development opportunities where you can truly discover your passion? Are you looking for a culture of openness, collaboration and trust where everyone has a voice? What about all of these? If so, then IBM could be your next career challenge. Join us, not to do something better, but to attempt things you never thought possible.

Impact. Inclusion. Infinite Experiences. Do your best work ever.

About IBM
IBMs greatest invention is the IBMer. We believe that progress is made through progressive thinking, progressive leadership, progressive policy and progressive action. IBMers believe that the application of intelligence, reason and science can improve business, society and the human condition. Restlessly reinventing since 1911, we are the largest technology and consulting employer in the world, with more than 380,000 IBMers serving clients in 170 countries.

Location Statement
For additional information about location requirements, please discuss with the recruiter following submission of your application.

IBM intends this job to be performed entirely outside of Colorado.

Being You @ IBM
IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.