Software Quality Assurance Manager
2 weeks ago
Lead and manage the embedded Software Quality assurance team ensure Software verification is conducted in accordance to the FDA standards to deliver high quality software.
Manage a team of 4-8 embedded software Quality assurance engineers.
Lead Design Control and Software Quality Assurance initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices and embedded Software.
Responsible for the generation, review and approval of design control documentation with primary focus on software development deliverables.
Collaborate with Project Management to support and optimize the schedules.
Support development teams on the validation of software tools.
Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on generation, documentation, verification and validation of requirements.
Lead creation of necessary documentation to comply with regulatory requirements and industry best practices.
Establish and maintain software quality assurance programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304.
Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
Provide guidance on and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management, Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to Quality Assurance activities in software development.
Work closely with the software development team to identify improvements.
Influence the requirements definition and software design to maximize testability.
Oversee and influence development of test objects to meet needs of protocol.
Develop and extend protocols and plans as device features evolve.
Participate in product design reviews.
Represent SQA in the core team meetings.
Creating and executing test plans, test designs and test cases and generating test reports for them.
Creating and updating Trace matrices between requirements and Tests.
Work with the scrum Master and product owners to prioritize or deprioritize the backlog.
Keep track of the Testing board and tools inventory for the team.
Performs other duties as required.
BS in Software Engineering, Computer Science or similar field; 8+ years hands on experience in software quality assurance associated with real time embedded software systems in regulated industry and/or equivalent combination of education and experience.
Experience of 1+ years being the Software QA Lead/Manager.
Thorough understanding of software quality assurance principles, practices and metrics as well as software development and testing best practices that foster high quality software.
Hands on experience using modern software development and quality assurance tools.
Proven record developing and executing software test protocols for complex medical devices.
Familiarity with IEC 62304, ISO 14971, FDA regulations and international standards applicable to medical device software development, verification and validation a plus.
Experience working with products from the prototype through 510(k)/ISO clearance and commercialization is preferred.
-
Manager Software QA Engineer R&D
1 week ago
Acton, United States CareerBuilder Full timeManager Software QA Engineer R&D (Hybrid) We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! Job Title: Manager, Software QA Department: R&D Position Overview: This position is...
-
Software Engineer
Found in: Appcast US C2 - 2 weeks ago
Acton, United States Product Insight, Inc. Full timeSoftware Engineer Product Insight is an integrated design & engineering firm helping B2B companies develop the technical products & systems that make a positive impact on our world. We believe that to achieve our vision, we need the best team possible. Our team members find creative solutions to complex technical challenges for businesses that develop...
-
Software Engineer
2 weeks ago
Acton, United States Product Insight, Inc. Full timeSoftware Engineer Product Insight is an integrated design & engineering firm helping B2B companies develop the technical products & systems that make a positive impact on our world. We believe that to achieve our vision, we need the best team possible. Our team members find creative solutions to complex technical challenges for businesses that develop...
-
Software Engineer
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Acton, United States Product Insight, Inc. Full timeSoftware Engineer Product Insight is an integrated design & engineering firm helping B2B companies develop the technical products & systems that make a positive impact on our world. We believe that to achieve our vision, we need the best team possible. Our team members find creative solutions to complex technical challenges for businesses that develop...
-
IT Project Manager
1 week ago
Acton, United States JLM Strategic Talent Partners Full timeWHO IS JLM STRATEGIC TALENT PARTNERS & WHAT IS OUR ROLE We partner with National & International prime contractors to provide them with qualified talent they can trust. We accomplish this by sourcing & vetting high level career seeking candidates in the industry and match them with our partners current open roles. Our objective is to help our general...
-
Center Director
3 days ago
Acton, United States AmSurg Full timeCenter Director Endoscopy Center of the Central Coast, San Luis Obispo, CA and Templeton Endoscopy, Templeton, CA Central Coast Endoscopy Centers are state-of-the-art, fully licensed ambulatory surgery centers equipped to perform both diagnostic and Director, Medical Director, Quality Assurance, Clinical Director, Healthcare, Patient Care
-
Regional Sales Manager
2 weeks ago
Acton, United States Wintriss Controls Group, LLC Full timeWintriss Controls Group LLC is currently looking for a motivated and Regional Sales Manager to join our sales team. The Regional Sales Manager will be responsible for managing a set of manufacturing reps throughout the US and Canada. This position is based out of our Acton Massachusetts office and will report to our National Sales...
-
Regional Sales Manager
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Acton, United States Wintriss Controls Group, LLC Full timeWintriss Controls Group LLC is currently looking for a motivated and Regional Sales Manager to join our sales team. The Regional Sales Manager will be responsible for managing a set of manufacturing reps throughout the US and Canada. This position is based out of our Acton Massachusetts office and will report to our National Sales...
-
Business Systems Analyst
1 week ago
Acton, United States Payright Workforce Solutions Full timeDescription Payright is a privately held company since 1989 has been proudly delivering innovative workforce solutions to thousands of organizations and serving Payroll and HR professionals. We offer tailored HCM solutions for businesses of all sizes. Our services range from basic payroll processing to integrated solutions incorporating payroll processing,...
-
Operations Manager
Found in: Appcast US C2 - 1 week ago
Acton, United States Novotech Inc. Full timeNovotech, Inc. is an exciting and growing company in the electro-optics industry. We manufacture products for the thermal imaging and infrared optical industries. At Novotech, we specialize in infrared optical blanks and components for use in our customers’ electro-optic and photonic devices. Novotech is a job shop, and manufactured products are always...
-
Operations Manager
1 week ago
Acton, United States Novotech Inc. Full timeNovotech, Inc. is an exciting and growing company in the electro-optics industry. We manufacture products for the thermal imaging and infrared optical industries. At Novotech, we specialize in infrared optical blanks and components for use in our customers’ electro-optic and photonic devices. Novotech is a job shop, and manufactured products are always...
-
Operations Manager
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Acton, United States Novotech Inc. Full timeNovotech, Inc. is an exciting and growing company in the electro-optics industry. We manufacture products for the thermal imaging and infrared optical industries. At Novotech, we specialize in infrared optical blanks and components for use in our customers’ electro-optic and photonic devices. Novotech is a job shop, and manufactured products are always...
-
Senior Manufacturing Engineer
3 days ago
Acton, United States CareerBuilder Full timeSENIOR SUPPLIER ENGINEER LOCATION Acton, Massachusetts COMPANY Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that...
-
Licensed Primary Counselor at Private Rehab
2 weeks ago
Acton, United States Bright Mission Recovery Full timeJob DescriptionJob DescriptionSalary: $26.00 - $35.00 per hour DOEBright Mission Recovery is looking to hire a substance abuse counselor for our detox and residential program.Position Title: CounselorJOB DESCRIPTIONThis position reports to the Clinical DirectorTo provide ongoing support and expertise through the provision of case management services,...
-
Construction Grading Foreman
1 week ago
Acton, United States RTG Investment LLC Full timeJob DescriptionJob DescriptionThe Grading Foreman is a field position that is responsible to organize and lead a crew to safely and efficiently perform mass earthwork balancing. As the liaison between workers and supervisors, the Grade Foreman is the key person in charge of overseeing the completion of the project and must be able to see the “big...
-
Administrative Assistant/Receptionist
1 week ago
Acton, United States MassNAELA Full timeBenefits: 401(k) matching Bonus based on performance Dental insurance Health insurance Opportunity for advancement Paid time off Vision insurance Company Overview Small, but busy, Acton law firm is seeking a full-time Receptionist/Administrative Assistant to join our team. This practice specializes in Elder Law which includes MassHealth/Medicaid...
-
Environmental Monitoring Technician I
Found in: Resume Library US A2 - 2 weeks ago
Acton, Massachusetts, United States Element Materials Technology Full timeOverview: Element has a current opening for an Environmental Monitoring Tech to join our growing team in Acton, MA. The Environmental Monitoring (EM) Department supports microbiological testing for cleanrooms that may be utilized by hospital pharmacies, and/or medical device and biotechnology companies to manufacture products such as parenteral medicines,...
-
Legal Receptionist
Found in: beBee S US - 2 weeks ago
Acton, United States Eckel, Hoag & O'Connor Full timeLegal Receptionist Small, but busy, Acton law firm is seeking a full-time receptionist to join our team. Primary responsibilities include answering and directing phone calls, managing incoming and outgoing mail, client reception, making and confirming appointments, drafting and proofreading letters and other documents, copying and scanning, filing and file...
-
Escrow Assistant
2 days ago
Acton, United States Pro R.E.A. Staffing Full timeJob DescriptionJob DescriptionWe are Priority Escrow of California, a DFPI licensed escrow company owned by Priority Title and Escrow, a nationwide title & escrow company. We believe in putting people before profits, a culture of care and respect, and always doing the right thing, even when it’s hard.While you will be plugged into a national brand, this...
-
Senior Staff Environmental Engineer
Found in: Resume Library US A2 - 6 days ago
Acton, Massachusetts, United States Geosyntec Consultants, Inc. Full timeOverview: Do you want to build an impactful career to change the world for the better? Geosyntec has an exciting opportunity for a Senior Staff Environmental Engineer to join our growing sediment & waterfront remediation practice in New England. The successful candidate will be based near one of our offices in Acton MA, Hamilton MA or Bedford NH. The...