Sr Quality Engineer
The Senior Software Quality Engineer will provide quality oversight for new product project teams responsible for the development of medical device software systems. Act as the subject matter expert in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.
POSITION DUTIES AND RESPONSIBILITIES:
- Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.
- Provide leadership, guidance and expertise on the software development process, procedures and practices.
- Partner with R&D to refine requirements, and to ensure that architecture/ design documents are comprehensive.
- Facilitate the documentation and tracking of verification activities, including code review findings.
- Review test case execution results and manage defects.
- Facilitate software risk assessment sessions and own the development of risk documents.
- Support regulatory filings and registrations
- Support internal and external audits or inspections of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations.
- Provide technical support for audits of software suppliers and software consultants.
- Conduct training on Medical Device Software development processes and quality systems.
- Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, IEC 62366.
- Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures, as well as medical device regulations.
- A Bachelor’s Degree is required. An Advanced Degree is preferred.
- Degrees in Engineering, Computer Science, Information Systems, Biomedical/Bioengineering Degree preferred.
- A minimum of 4 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity is required.
- The ability to apply appropriate Quality tools/systems/processes to meet department goals and objectives is required.
- Demonstrated ability to effectively partner across functional areas is required.
- Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets is required.
- The ability to utilize written and oral communication skills to meet departmental goals/objectives is required.
- Extensive use and knowledge of personal computer and associated work tools (Word, Excel, Power Point) is required.
- Medical device industry experience.
- ASQ certification as a Software Quality Engineer, or equivalent, is preferred
This position will be based in a MA location and may require up to 10% domestic and/or international travel.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.