Senior Design Quality Assurance Engineer - Medical Device #0436

About ECI ECIs mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. This is a remote role. What You'll Do The major task is a design control gap assessmentDesign inputs/product requirements and risk management Test method - is the equipment appropriate for the design input; does it meet current standard of work instructionProvide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)Develop quality documentation such as quality plans, standard operating procedures, and inspection procedures. Ensure regulatory, FDA, and ISO compliance in all areas of responsibilitiesRepresent Quality initiatives and compliance when participating and Design and Phase reviewsServe as an effective leader and team member in supporting quality disciplines, decisions, and practicesEnsure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentationEnsure the use of statistically valid sampling techniques and teach others on the use of these and other advanced statistical techniques such as DOE and evaluationsProvide direction and lead the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance criteriaApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesProvide support for CAPA/NCRs/ComplaintsAssists with special projects as needed. What you will bring Bachelors degree in engineering or equivalent work experienceMinimum of 3-5 years direct R&D experience in medical device industry working with Capital EquipmentExperience with durable medical capital equipment addition to single-use devices is preferredExcellent written and verbal communication skills with good presentation and technical writing skillsCollaborative attitude with the ability to work well in a team environmentStrong engineering, design, and analysis skills along with experience with medical devices from concept to commercializationUnderstanding of FDA Quality Systems RegulationsDemonstrated use of quality tools and methodologies including SPC, DOE, GR&R, FMEA, CAPA, and process validation (IQ, OQ/PQ). Must have a good understanding of FDA 21CFR820, ISO 13485, 14971, and 11607 standards. ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.