Software Quality Assurance Manager Hologic, Inc.
Westford, MA

Job Description

At Hologic, we're an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we've been able to expand our offerings to empower even more people and champion women's health

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women's health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

Job Summary

Manage all aspects of software validation activities for a leading medical device manufacturer. Lead a team of SQA engineers to conduct product validations per design controls; develop and integrate test automation; maintain and support software-related regulatory and production activities.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Manage and maintain all activities related to software quality assurance

* Plan, coordinate and evaluate verification and validation (V&V) activities for all projects.
* Report to Director of Software and be responsible for all SQA hiring and ongoing staffing needs.
* Interact with Project Managers to ensure timely project completion (or release); may include contributing to resolution of product or project problems.
* Develop or coordinate V&V technical plans and complex test protocols.
* Continually gather related information for user scenarios or occurrences that can help in the validation strategies for ongoing improvements.
* Facilitate V&V efforts with cross-functional teams from multiple departments to determine schedules and best methods for obtaining verification solutions.
* . Execute all test plans, and provide corresponding test results summary reports.
* . Oversee the generation of detailed defect reports; conducting regular triage meetings as necessary.
* Monitor and update software Standards documentation to reflect ongoing software life cycle practices.
* Maintain documentation for test tools and test fixtures used for validation.
* Communicate ongoing test status to management.
* Originate software Change Orders (ECOs) using the company ERP system.
* Provide guidance to the software group to successfully release and archive all controlled documents and data.

Plan and implement test automation when possible per identified project V&V needs

* Champion conversion from manual testing to test automation
* Knowledge of CodedUI or other test automation tools to help in the automation of software testing.
* Collaborate with software development staff to process ongoing status of workitem tasks.
* Evaluate software requirement completeness, processing of change requests and resolving bug fixes.
* Integrate the quality assurance component of the software department with Agile development practices.

Develop relationships with MFG, Clinical, QA, and RA departments in order to integrate software-related concerns and deliverables. Includes:

* Quality and Quality Engineering: for alignment of changes and updates for incoming and final QC processes, product-specific risk management files, and compliance with IEC-62304.
* Regulatory Affairs: for meeting all regulatory design controls compliance needs, including 510(k) submission documentation, international product registry document requirements, and representing the software department during internal and external audits.
* Manufacturing: for ensuring that post release process procedures can be executed as intended on new or updated software releases, coordinate confirmation with off-site MFG suppliers when necessary.
* Service: for conveying software-related issues that impact customer support, provide V&V support for updates and maintenance to workstations.
* Clinical: for confirming that software implementation accommodates user and patient practices.

Qualifications

* 10+ years of professional experience working in a Software QA role
* 5+ years supervisory responsibilities as manager and project lead
* Demonstrated ability to maintain a high level of attention to detail

Education

* Master's degree or Bachelor's degree in EE, CS, or a related field

Experience

* Practical compliance with medical device environment; FDA, ISO and IEC62304 requirements
* Hands-on testing of complex hardware and software embedded systems, in particular laser and RF-based devices
* Software development: Test automation (development, execution and maintenance); fluent with Coded-UI libraries, C#
* Working knowledge of test management software: prefer Project management (and defect tracking with Team Foundation Server (TFS) 2017 ; Visual Studio Test Professional ; Microsoft Test Manager

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.