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Quality Engineer II/Quality Engineering Analyst II - Watson Health

Company: IBM
Location: Hartland
Posted on: November 22, 2021

Job Description:


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

IBM Watson Health is seeking a Quality Engineer II / Quality Engineering Analyst II who will be a member of the Watson Health RAQA Organization you will support the Quality Management System, including: Design Assurance, Corrective Action/Preventative Action (CAPA), Production/Process Controls, Supplier Management, Complaints and Post Market Surveillance processes. You will use your knowledge of global Medical Device regulations and standards to support premarket design and development and post market surveillance processes for Watson Health. This will include participation in Design Control Activities, CAPA resolution, complaints investigations, recalls activities and production/process controls. You will interface with the functional leaders in development, offering management, fulfillment, solution teams, regulatory, legal and other stakeholders to support QMS compliance.

Preferred location: Cambridge MA, Hartland WI or Remote

Essential Job DutiesUnderstanding of the established quality system in accordance with applicable regulations in USA, Canada, Brazil, Japan, EU, UK, Australia and Singapore at a minimum

Under minimal supervision, work directly with program teams to ensure compliance to design controls during new product introduction and maintenance activities.

Guide functional objectives as they relate to compliance with the established QMS.

Under minimal supervision, works in conjunction with team members to develop, implement, maintain, and improve the quality system to ensure that the quality system is established and maintained in accordance with the requirements of the FDA and other regulatory agencies, certification bodies, and standards organizations.

Participates in internal and external audits. Conducts internal audits as lead and/or auditor per the audit schedule. Participates in FDA and other regulatory inspections.

Works with cross functional team members to investigate and propose solutions to identified issues. Tracks CAPA investigations through completion to ensure identified nonconformances are corrected and recurrence prevented.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Recognizes complex problems related to functional objectives and applies sound judgement when addressing QMS related issues.

Analyzes situations and proposes solutions to QMS and business needs by developing/modifying QMS procedures and processes.

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

Performs supplier qualifications and reviews, including participation in desk audits and/or on-site audits of suppliers as required.

Generates quality metrics and reports for Management Reviews at prescribed intervals as needed.

Performs all duties and responsibilities as required by the Quality Management System Policies, Procedures and Work Instructions.

Performs other duties as assigned by immediate supervisor or upper management


Required Technical and Professional Expertise

BA/BS in a scientific discipline in a scientific or technical discipline.

Minimum of 5 years in healthcare medical device or life sciences pharmaceutical design and/or manufacturing role and a minimum of 2 years with job title/experience related to Quality Engineer, Quality Systems or Regulatory Affairs.

General understanding of product development process and design control

Proficiency with Microsoft Word, Excel and PowerPoint required.

Effective written and oral communication, technical writing and editing skills

Ability to work independently with minimal supervision

Work experience in a software development company preferably in the Cloud and Mobile platform industry segment.

Understands and has experience with compliance to a quality system in accordance with applicable regulations in USA, Canada, Brazil, Japan, EU, UK, Australia and Singapore.

Understands the WH/WHI QMS and the processes that support the QMS.

Excellent interpersonal, communication, and negotiation skills

Familiar with database entries and queries

Preferred Technical and Professional Expertise

Minimum of 6 years in healthcare medical device or life sciences pharmaceutical design and/or manufacturing role and a minimum of 3 years with job title/experience related to Quality Engineer, Quality Systems or Regulatory Affairs.

Preferred Master's Degree

Preferred experience working on eHealth or software-as-a-device (SaMD), software-driven medical devices

Preferred experience with ISO14971, ISO62304 and ISO62366.

Preferred professional certifications: CQE, RAPS, etc.

About Business Unit

IBM's Cloud and Cognitive software business is committed to bringing the power of IBM's 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 environments-with 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.

This job requires you to be fully COVID-19 vaccinated prior to your start date, where legally permissible. Proof of vaccination status will be required. If you are unable to be vaccinated due to medical, pregnancy or religious reasons, we offer accommodations in accordance with applicable law.

Your Life @ IBM

Are you craving to learn more? Prepared to solve some of the world's most unique challenges? And ready to shape the future for millions of people? If so, then it's time to join us, express your individuality, unleash your curiosity and discover new possibilities.

Every IBMer, and potential ones like yourself, has a voice, carves their own path, and uses their expertise to help co-create and add to our story. Together, we have the power to make meaningful change - to alter the fabric of our clients, of society and IBM itself, to create a truly positive impact and make the world work better for everyone.

It's time to define your career.

About IBM

IBM's greatest invention is the IBMer. We believe that through the application of intelligence, reason and science, we can improve business, society and the human condition, bringing the power of an open hybrid cloud and AI strategy to life for our clients and partners around the world.

At IBM, we pride ourselves on being an early adopter of artificial intelligence, quantum computing and blockchain. Now it's time for you to join us on our journey to being a responsible technology innovator and a force for good in the world.

Location Statement

IBM offers a wide range of resources for eligible IBMers to thrive both inside and outside of work. In addition to a competitive benefits program consisting of medical and life insurance, retirement plans, and time off, eligible employees may also have access to:

--12 weeks of paid parental bonding leave. Family care options are also available to support eligible employees during COVID-19.

--World-class training and educational resources on our personalized, AI-driven learning platform. IBM's learning culture supports your restless attitude to grow your skills and build the depth and scale of knowledge needed to achieve your career goals.

--Well-being programs to support mental and physical health.

--Financial programs that empower you to plan, save, and manage your money (including expert financial counseling, 401(k), IBM stock discount, etc.).

--Select educational reimbursement opportunities.

--Diverse and inclusive employee resource groups where you can network and connect with IBMers across the globe.

--Giving and volunteer programs to benefit charitable organizations and local communities.

--Discounts on retail products, services, and experiences.

This position is eligible for participation in an IBM sales incentive plan. Actual incentive opportunity will be based on performance and the eligible Target Incentive, as addressed in the applicable plan, all of which is subject to change.

We consider qualified applicants with criminal histories, consistent with applicable law.

IBM will not be providing visa sponsorship for this position now or in the future. Therefore, in order to be considered for this position, you must have the ability to work without a need for current or future visa sponsorship.

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.

Keywords: IBM, Milwaukee , Quality Engineer II/Quality Engineering Analyst II - Watson Health, Engineering , Hartland, Wisconsin

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