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Hologic Senior Software Quality Engineer, Global Quality Systems in Marlborough, Massachusetts

Senior Software Quality Engineer, Global Quality Systems

Post Date Nov 20, 2020

Our PURPOSE—to enable healthier lives everywhere, every day—is driven by a PASSION to become global champions for women’s health. We succeed by fulfilling our PROMISE to bring The Science of Sure ® to life through product quality, clinical differentiation, customer relationships and our team’s talent and engagement.

Our Purpose is simple: to enable healthier lives everywhere, every day. Toward this end, we offer clinically proven products designed to detect, diagnose and treat disease and other health conditions that primarily affect women—earlier and more accurately than ever to provide ever greater certainty and peace of mind. This focus has fueled our long track record of innovative medical breakthroughs across many therapeutic areas—breast health, cervical health, body composition, gynecologic health, perinatal health, skeletal health and sexual health—touching the lives of more than 230 million women around the world every year. In fact, as global champions for women’s health, no company in the world has done more to fight cervical and breast cancer than Hologic—and we will continue to challenge ourselves to ensure that future generations of women have access to our life-saving innovations.

Of course, none of this would be possible without the talent and passion of our employees. Together, our collective expertise and dedication to develop and market robust, science-based certainty sustain a pipeline of exceptional solutions that respond to the unmet health and wellness needs of women, families and communities. And when we fulfill our purpose and promise to the world, we also fulfill another goal: a business that generates sustainable global financial growth from which success and prosperity for our company, employees and investors naturally follow.

Job Summary

Responsible for the global Corporate Quality Systems software validation program including the process, procedures, and training. This would include gathering business requirements for system updates and upgrades to the software systems used. Works closely with the Corporate process owners and IS to ensure all appropriate documentation is developed to support validation and verification activities. Maintain the validation paperwork in support of Corporate quality systems software and following the Software Development Life Cycle (SDLC) process as per the governing procedures for Quality System Software Validation.

Essential Duties and Responsibilities

The incumbent may be asked to perform otherfunction-related activities in addition to the below mentioned responsibilitiesas reasonably required by business needs.

  • Oversight and coordination of software validationactivities by working with project teams to assure Corporate non-product qualitysystems are properly validated in accordance with the relevant procedures.

  • Maintenance and ownership of Corporate Quality SystemValidation procedures and process and work instructions, includingimplementation of continuous improvement activities and training.

  • Support the development of business requirementswith the relevant Corporate process owners for system changes.

  • Lead the assessment of enterprise software changesto determine validation needs.

  • Responsible for addressing the root cause (CAPAs) orpotential root cause related to the corporate Quality System validationconcerns.

  • Creation of the validation plans, reports and othervalidation documentation supporting projects and maintain up to date validationpaperwork in the document management system.

  • Develop and drive project plans to support thetimely implementation of software changes.

  • Provide expert guidance to sites on validationrequirements based on Corporate procedures and requirements.

  • Supports third party audits/inspections regardingEnterprise system validation processes and documentation.

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Sit;use hands to finger, handle or feel objects, tools, or controls.

  • Stand;walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

Qualifications

Education

  • BS/MS degree or equivalentin an engineering, science or information systems discipline

Experience

  • Minimum 5 years relatedexperience in a regulated industry with at least three years recent experiencein Medical Devices OR equivalent combination of education and experience

Skills

  • Able to use MicrosoftOffice programs, business systems and spreadsheet programs

  • Excellent written, verbal and presentation skills

  • Excellent interpersonal skills to interact with alllevels of the company and oversight agencies

  • Strong working knowledge of software validation

  • Attention to detail

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