Senior Design Quality Assurance Engineer - Medical Device #6832

ECI; Arden Hills (MN); Remote; USD 110,000 - 160,000; Full time

Job summary

ECI is seeking a quality-focused professional for a remote role in the life sciences space. The work centers on a design control gap assessment and providing quality and regulatory input across project teams during decisions and deliverables.

Responsibilities include developing quality documentation, leading design reviews, and ensuring FDA/ISO compliance throughout product development. Strong communication and collaboration are essential for success in this role.

Qualifications

• Bachelor's degree in engineering or equivalent work experience.
• 5-10 years' direct R&D experience in medical device industry.
• Experience in ops quality and design quality.
• Excellent written and verbal communication skills.
• Collaborative attitude with the ability to work well in a team environment.
• Strong engineering, design, and analysis skills with medical devices from concept to commercialization.
• Understanding of FDA Quality Systems Regulations.
• Demonstrated use of quality tools including SPC, DOE, GR&R, FMEA, CAPA, and process validation.
• Knowledge of FDA 21CFR820, ISO 13485, 14971, and 11607 standards.

Responsibilities

• The major task is a design control gap assessment.
• Provide input on design inputs/requirements and risk management.
• Support project teams with decisions and deliverables (e.g., Design Change Analysis, Design Inputs/Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, Labeling).
• Develop quality documentation such as quality plans, SOPs, and inspection procedures; ensure FDA/ISO compliance.
• Represent Quality initiatives during Design and Phase reviews and lead quality discussions.
• Lead and collaborate on quality disciplines and decision-making practices.
• Document product requirements (PR) and perform quarterly gap analyses; review verification docs.
• Teach statistically valid sampling and advanced statistics (DOE, etc.).
• Direct Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans and testing.
• Apply systematic problem-solving to identify, prioritize, and resolve quality issues.
• Provide support for CAPA/NCRs/Complaints and assist with special projects.

Skills

Quality systems

Quality documentation

Regulatory knowledge

Statistical methods

Education

Bachelor's degree in engineering

Tools

DOE

SPC

GR&R

FMEA

CAPA

Process validation

IQ/OQ/PQ

Job 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.

This is a remote role.

• 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.

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.

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 5-10 years' direct R&D experience in medical device industry working with electromechanical devices (single use devices)


• Experience in ops quality and design quality


• 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 candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.