Senior Quality Engineer – Medical Devices & Process

ECI; Taunton (MA); On-site; USD 95,000 - 130,000; Full time

Job summary

ECI in Taunton, MA seeks a Senior Quality Engineer to enhance production processes for high-quality, compliant medical devices. You will collaborate with cross-functional teams to drive quality initiatives, ensure regulatory compliance, and support Design Assurance activities including DV/VAL/usability.

Qualified candidates bring 5+ years in QA/Design QA for medical devices, strong problem-solving, and proficiency with DOE, GR&R, FMEA, and CAPA. Excellent communication and teamwork are essential.

Qualifications

• Bachelor’s degree in engineering required.
• 5–8 years of Quality/Design Quality engineering in medical devices.
• Experience with FDA 21 CFR 820, ISO 13485, 14971, and 11607.
• Strong communication and teamwork skills.
• Proficiency with quality tools: SPC, DOE, GR&R, FMEA, CAPA, and process validation.

Responsibilities

• Review and approve change requests for product, process, and validation docs.
• Develop quality documentation: quality plans, SOPs, inspection procedures.
• Ensure regulatory, FDA, and ISO compliance across responsibilities.
• Represent Quality initiatives in Design and Phase reviews.
• Apply DOE, ANOVA, and statistically valid sampling techniques.
• Review Process Qualifications, Test Methods, Gage R&R, FMEA, CAPA.
• Support CAPA/NCRs/Complaint evaluations.
• Lead Acceptance Activities, First Article Inspections, sampling plans.
• Provide problem-solving to identify and resolve quality issues.
• Assist in special projects and team duties.

Skills

Quality engineering

DOE

GR&R

FMEA

CAPA

Process validation

Statistical methods

FDA 21 CFR 820

ISO 13485

Medical devices

Education

Bachelor’s degree in Engineering

Job description

ECI in Taunton, MA seeks a Senior Quality Engineer to enhance production processes for high-quality, compliant medical devices. You will collaborate with cross-functional teams to drive quality initiatives, ensure regulatory compliance, and support Design Assurance activities including DV/VAL/usability.

Qualified candidates bring 5+ years in QA/Design QA for medical devices, strong problem-solving, and proficiency with DOE, GR&R, FMEA, and CAPA. Excellent communication and teamwork are essential.