Senior Design Quality Assurance Engineer - Medical Device #0436

Enhanced Compliance Inc.; United States; On-site; USD 90,000 - 125,000; Full time

Job summary

ECI is a remote role focused on quality and regulatory responsibilities within medical device development. The major tasks include design control gap assessments, risk management, and ensuring that design inputs, outputs, test methods, and validation activities meet current standards.

You will develop quality documentation, participate in design reviews, and provide guidance on CAPA, NCRs, and complaints to project teams. Strong FDA/ISO knowledge and communication skills are essential.

Qualifications

• 3–5 years of direct R&D experience in medical devices.
• Experience with capital equipment; single-use devices preferred.
• Strong knowledge of FDA QSR, ISO 13485, 14971, and 21 CFR 820.
• Excellent written and verbal communication and technical writing.
• Ability to work in a team and lead quality initiatives.

Responsibilities

• Design control gap assessment.
• Define design inputs and risk management activities.
• Provide quality input to project teams for decisions and deliverables.
• Develop quality documentation and ensure regulatory compliance.
• Lead quality initiatives during design reviews and V&V.
• Support CAPA/NCRs/Complaints.
• Assist with special projects as needed.

Skills

Quality assurance

Regulatory compliance

Statistical analysis

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

SPC

DOE

GR&R

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 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 3 rd party vendor.