Hardware Systems Quality Assurance Manager

AP Professionals has partnered with a medical device company looking to add a Hardware Systems Quality assurance. As a member of the Research and Development QA Engineering team, this hands-on manager supervises a team of Hardware QA Engineers and Technicians. In this role, they are accountable for designing system tests, formulating test plans, and overseeing the execution of tests across a range of system products.

This position is not eligible for VISA sponsorship.

• Oversees a team of hardware quality assurance engineers and technicians.
• Assumes responsibility for guiding and facilitating the design verification of new product developments, ensuring the seamless transition of the design to manufacturing while ensuring compliance with regulatory requirements.
• Contributes expertise to new product development and manufacturing by addressing design verification and validation, regulatory compliance, specification development, measurable objectives, hazard and safety assessments, and other quality-related aspects essential for achieving project goals across hardware, software, and manufacturing domains.
• Leads product design teams in conducting comprehensive Failure Mode Effects Analysis (FMEA) activities.
• Formulates and executes test plans.
• Develops intricate schedules and resource plans for the verification and validation phases of product design projects.
• Thoroughly documents and archives all test outcomes, analyses, and test summary reports.
• Advocates for the customer's perspective in project-related quality determinations.
• Establishes clear scope definitions, implements innovative tools, drives change management initiatives, and defines metrics to measure successful project completion.
• Provides support for regulatory agency audits and inspections.
• Manages verification activities associated with design changes, including test assignments for updates to existing products.

• A Bachelor's degree in Engineering, with a preference for Electrical Engineering, Imaging Science, or a background in the Clinical domain, particularly in medical device engineering.

• A minimum of 5 years of demonstrated engineering expertise.
• A minimum of 5 years of proven leadership experience in a Quality Assurance role is highly desirable.

• Proficiency in offering guidance and utilizing statistical tools.
• Demonstrated capacity for data-driven decision-making.
• The ability to exert influence within peer groups and at higher management levels.
• Experience in Quality Engineering, manufacturing, or service roles within the FDA-regulated medical device industry.
• Proficiency in handling regulatory audits, including ISO 9001, ISO 13485, and FDA assessments.
• Capable of using statistical software tools like Minitab, Reliasoft, etc.
• Possession of ASQ Certification (CQE, CRE).
• Familiarity with V-model verification and validation methodologies.
• Certification as a Six Sigma Black Belt or Green Belt.
• Competent in utilizing quality tools such as Reliability analysis, FMEA (Failure Mode and Effects Analysis), fault tree analysis, root cause analysis, fishbone diagrams, Design of Experiments (DOE), Analysis of Variance (ANOVA), Cpk analysis, and more.