Senior R&D Quality Engineer - Medical Devices

ECI; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

ECI, a leader in life sciences consulting, seeks a Quality Assurance professional to drive regulatory compliance across the product lifecycle. You will influence design changes, create quality documentation, and ensure adherence to FDA/ISO standards while coordinating with cross-functional teams on CAPA, V&V, and inspections.

Ideal candidates have 5–6 years in medical device R&D, strong analytical skills, and a collaborative mindset to support quality initiatives from concept through

Qualifications

• Bachelor's degree in engineering or equivalent work experience.
• Minimum 5–6 years of direct R&D experience in medical device industry with electromechanical devices.
• Experience with durable medical capital equipment and single-use devices is preferred.
• Excellent written and verbal communication skills with good presentation and technical writing skills.
• Collaborative attitude and 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.

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, SOPs, and inspection procedures; ensure FDA/ISO compliance.
• Represent Quality initiatives and compliance during Design and Phase reviews.
• Lead and support quality disciplines, decisions, and practices.
• Ensure product requirements are documented and validated with quarterly gap analyses and verification records.
• Apply statistical sampling techniques and teach others about DOE and ANOVA.
• Direct Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, testing, and acceptance criteria.
• Use sound problem-solving methodologies to identify and resolve quality issues.
• Support CAPA/NCRs/Complaints and assist with special projects.

Skills

Quality mindset

Communication skills

Team collaboration

Problem solving

Regulatory awareness

Education

Bachelor's degree in engineering or equivalent

Tools

DOE

GR&R

FMEA

CAPA

Process validation

IQ/OQ/PQ

FDA 21 CFR 820

Job description

ECI, a leader in life sciences consulting, seeks a Quality Assurance professional to drive regulatory compliance across the product lifecycle. You will influence design changes, create quality documentation, and ensure adherence to FDA/ISO standards while coordinating with cross-functional teams on CAPA, V&V, and inspections.

Ideal candidates have 5–6 years in medical device R&D, strong analytical skills, and a collaborative mindset to support quality initiatives from concept through