A remote senior design quality assurance role for medical devices: the engineer leads a design control gap assessment and provides quality/compliance input on design inputs, V&V, validations, and labeling. Core work involves FDA/ISO compliance, quality documentation, CAPA/NCR support, and statistical quality tools like SPC, DOE, GR&R, and FMEA.
ECI’s 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 assessment
Design inputs/product requirements and risk management Test method - is the equipment appropriate for the design input; does it meet current standard of work instruction
Provide 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 responsibilities
Represent Quality initiatives and compliance when participating and Design and Phase reviews
Serve as an effective leader and team member in supporting quality disciplines, decisions, and practices
Ensure 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 documentation
Ensure the use of statistically valid sampling techniques and teach others on the use of these and other advanced statistical techniques such as DOE and evaluations
Provide direction and lead the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance criteria
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Provide support for CAPA/NCRs/Complaints
Assists with special projects as needed.
What you will bring
Bachelor’s degree in engineering or equivalent work experience
Minimum of 3-5 years’ direct R&D experience in medical device industry working with Capital Equipment
Experience with durable medical capital equipment addition to single-use devices is preferred
Excellent written and verbal communication skills with good presentation and technical writing skills
Collaborative attitude with the ability to work well in a team environment
Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization
Understanding of FDA Quality Systems Regulations
Demonstrated 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.