Senior Design Quality Assurance Engineer - Medical Device #6832

Enhanced Compliance Inc.; United States; A distancia; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Enhanced Compliance Inc. is seeking an experienced Quality Assurance professional to lead design control gap assessments and drive regulatory compliance for medical devices in a fully remote role across the United States.

You will develop quality documentation, support CAPA/NCR processes, and provide input on Design Change Analysis, Design Inputs/Outputs, Test Methods, and V&V to support project teams from concept to commercialization.

Formación

• 5–10 years direct R&D experience in medical device industry.
• 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 for medical devices from concept to commercialization.
• Understanding of FDA Quality Systems Regulations (QSR).
• Familiarity with quality tools and methodologies including SPC, DOE, GR&R, FMEA, CAPA and process validation.

Responsabilidades

• Lead design control gap assessments and define critical inputs/outputs.
• Develop quality documentation such as quality plans, SOPs, and inspection procedures.
• Provide regulatory input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs/Outputs, Test Methods).
• Support CAPA/NCRs/Complaints and participate in design reviews, V&V, usability testing, and process validation.

Conocimientos

R&D experience

Ops quality

Design quality

Communication skills

Team collaboration

FDA QSRs

Quality tools

Herramientas

SPC

DOE

GR&R

FMEA

CAPA

IQ/OQ/PQ

Descripción del empleo

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 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 3 rd party vendor.