Software Quality Specialist Job Listing at Kelly Services in Clearwater, FL (Job ID 9370712)

Description

Software Quality Specialist | Clearwater, FL

Full Benefits (medical, dental, vision, 401K, etc), PTO, paid holidays

Contract-To-Hire

 

Objectives / Purpose of the Job

Support the validation of software for manufacturing processes in a medical device regulated environment.

 

Key Activities / Responsibilities

Execute Software Quality Assurance activities in compliance with applicable policy and procedures. Assure compliance to all Global Software Quality Assurance initiatives, directives, and procedures. Provide training to respective groups on all Global Software Quality Procedure and their associated templates. Be responsible for the review and approval of all validation project documentation and assurance that the project meets all B+L and regulatory requirements. Some of the Software Quality Assurance activities may include authoring validation plans, assisting in developing test scripts, training the project team in software validation practices as it relates to GMP, reviewing /approving validation documents, following through on critical action items, and supporting the development of validation reports and overall B+L software validation effort.

 

Qualifications

• Degree in computer science or related technical degree
• 13485, ISO 9001, GMPs, MDR required. CMDR, JPAL, ISO 14001, OHSAS 18001, and other regulations are desired.
• knowledge and experience in a regulated medical device or pharmaceutical industry and experience with managing external agency audits necessary.
• understanding of 21CFR11 electronic signature and Data Integrity requirements.
• Certified Software Quality Engineer (CSQE) would be a plus but not a prerequisite. Solid experience with leading project teams by providing guidance and recommending changes.
• written and oral communication and interpersonal skills.
• knowledge of PLC, MMI (man / machine interface), SCADA, and machine control systems. Computer & Information Technology Skills including Windows, Word, Excel, Power Point, Project, Visio, statistical software (i.e. Minitab).
• years hands on experience in automated manufacturing processes. 3+ year's hands-on experience with Software Quality in a GxP environment

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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