ECI - Senior Quality Engineer - Combo Device

Brief Description About ECI 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. About The Role The Senior Quality Engineer's primary role is to enhance production processes to ensure efficiency, quality, and safety. You MUST have experience working with combination devices. It would be ideal if the candidate had experience specifically with "drug-coated" devices. Experience with 21 CFR part 211 and/or part 4 is a must. This role requires collaboration with cross-functional teams, strong problem-solving abilities, and a deep understanding of manufacturing systems to drive success. What You'll Do Review and approve change requests related to Product, Process, and Validation and Verification documentation. Experience with 21 CFR Part 211 and/or part 4 Experience working hands on with combination devices (Drug-Coated combination devices preferred.) 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 Identify industry best practices. Act as an effective leader or 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 ANOVA Review and approve Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), FMEAs (Design and Process), and production master control plans. Provide support for CAPA/NCRs/Complaint 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. Assists in special projects as needed. Contributes to team effort by accomplishing related duties as requested. What You Will Bring Bachelor’s degree in engineering. Minimum of 6-8 years direct Quality/Design Quality engineering experience in medical device industry required. Demonstrated used of quality tools/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. Demonstrated interpersonal skills with the ability to work within a team environment. Excellent written and verbal communication skills with good presentation and technical writing skills. Proficiency in all Microsoft Office programs. Good analytical and problem-solving skills. Strong engineering, design, and analysis skills. Working knowledge of tooling and manufacturing processes. Experience with medical devices from concept to commercialization. Understanding of FDA Quality Systems Regulations. Hands-on CAPA ownership, including root cause analysis, implementation, and effectiveness verification. Experience with NCEP (or similar quality event systems) for investigation, documentation, trending, and closure. Experience with pharma / combination products (e.g., antimicrobial or drug-coated devices) and associated regulatory considerations. 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 candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.