We are looking for an experienced Senior Software Quality Engineer to support the validation of non-product software systems and tools within the quality management system (QMS). This role will ensure compliance with FDA regulations and medical device industry best practices, oversee quality approvals, and support product release. The ideal candidate will be a subject matter expert (SME) in non-product software validation within a highly regulated environment. **Job Title: Senior Software Quality Engineer** **Location: Marlborough MA, Manchester, NH (Hybrid or Remote)** **Pay rate: $50/hr.** **Job Responsibilities And Essential Duties** + Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards (e.g., 21 CFR Part 11, IEC 62304, ISO 13485). + Own the quality approval process for software components, including documentation review and final release approvals. + Act as the subject matter expert (SME) and work with the software product team to maintain, refine and improve the processes (policies, standard operating procedures (SOPs), and supporting documentation) for this area of the quality system. + Partner with the software engineering team to implement and maintain a robust software quality management system. + Establish yourself as a trusted advisor to the Enterprise Applications team, with a problem-solving approach and a willingness to listen to the engineers and ensure the processes and documentation align with current regulations and best practices. + Support projects with the IT Engineering team to automate documentation processes based on agreed project plans. + Support the IT and Engineering teams following established service level agreements (SLA’s) and tracking key performance indicators (KPI’s). + Communicate project and compliance issues to Quality Systems Management and provide solutions to mitigate potential risks + Develop and support the teams that execute validation protocols, test scripts, and traceability matrices to ensure software functionality, reliability, and regulatory compliance. + Provide expertise in risk management for software risk assessments. + Lead internal and external quality audits and investigations related to software validation and compliance. + Collaborate with cross-functional teams, including regulatory, engineering, and operations, to support overall non-product software lifecycle management. + Supports QA department to determine documentation needs. Establish and improve necessary document templates and guide staff to support project needs and maintain site compliance with good documentation practices and cGxP data integrity requirements. + Stay up to date with evolving FDA, ISO, and other regulatory requirements for product software quality and validation. **Minimum Requirements** + Bachelor's degree in life sciences, engineering, or math preferred; or equivalent combination of education and experience. + 5 + years of quality experience in the pharmaceutical, biotech, or medical device industries. + 3+ years of experience in non-product software validation within an FDA-regulated environment and experience with releasing software product in multiple regulated geographies. **Required Knowledge, Skills And Abilities** + Project management tracking and trending experience preferred. + Experience with all aspects of the non-product software validation process in a regulated industry. + Strong understanding of FDA regulations, ISO 13485, and 21 CFR Part 11. + Experience with auditor interaction in internal quality audits, regulatory inspections, and nonconformance investigations. + Experience with agile practices in non-product software validation and lifecycle management. + Ability to work independently with little oversight; self-starter, action oriented. + Demonstrated ability to develop and oversee execution of product software validation plans and report generation and other related documentation. + Excellent communication and leadership skills, with the ability to work cross-functionally. + Experience in startup or fast-paced environments is a plus. If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! **About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells** _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent. ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.