Quality Engineer II - Medical Device #5453

About the role

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.

Responsibilities

• 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 in 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 ANOVA 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.
• Assist with special projects as needed.

Requirements

• Bachelor’s degree in engineering or equivalent work experience.
• Minimum of 3-5 years’ direct R&D experience in the medical device industry.
• Experience with durable medical capital equipment in 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.
• Must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI or another 3rd party vendor.