Quality Engineer II - Medical Device #8665

Theuniversityunion; California (MO); Hybrid; USD 95,000 - 130,000; Full time

Job summary

ECI seeks a Quality professional with hands-on R&D experience in the medical device field to lead design control and regulatory activities. You will assess design controls, risk management, and test methods, ensuring FDA/ISO compliance across the product lifecycle.

You’ll develop quality plans, participate in design reviews, and guide CAPA and process validation. Strong communication, teamwork, and a solid understanding of FDA 21 CFR 820, ISO 13485, 14971, and 11607 are required.

Qualifications

• 3–5 years of direct R&D experience in medical devices.
• Experience with durable medical capital equipment and single-use devices preferred.
• Excellent written and verbal communication with presentation and technical writing skills.
• Understanding of FDA Quality Systems Regulations.
• Knowledge of FDA 21 CFR 820, ISO 13485, 14971, 11607.

Responsibilities

• Lead design control gap assessments and risk management activities.
• Contribute to quality and compliance decisions (e.g., Design Change Analysis, Design Inputs/Outputs, Test Methods, D&V).
• Develop quality documentation and ensure FDA/ISO compliance.
• Represent quality in design and phase reviews; lead CAPA/NCR activities.
• Support acceptance activities, sampling plans, and process validation.
• Apply statistical approaches (DOE, SPC) and teach their use to teammates.

Skills

R&D experience

Quality tools

Team player

Tools

SPC

DOE

GR&R

FMEA

CAPA

Process validation

Job description

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

• Minimum of 3-5 years’ direct R&D experience in medical device industry working with electromechanical and cardiac rhythm devices
• 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.

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 3 rd party vendor.