Senior Quality Engineer, Medical Devices

Theuniversityunion; Taunton (MA); On-site; USD 90,000 - 140,000; Full time

Job summary

ECI seeks a Senior Quality Engineer to enhance production processes with cross-functional collaboration, ensuring efficiency, quality, and safety. You will support QS integration, maintain compliance matrices, and contribute to Design Assurance activities including DV, DVAL and Usability.

You will review change requests, develop quality docs, and lead quality initiatives across product and process reviews in a regulated medical-device environment.

Qualifications

• Minimum five (8) years direct Quality/Design Quality engineering experience in medical device industry.
• Must demonstrate use of quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, and process validation.
• Understanding of FDA 21 CFR 820, ISO 13485, 14971, and 11607 standards.
• Excellent written and verbal communication skills; strong presentation and technical writing skills.

Responsibilities

• Review and approve change requests related to Product, Process, and Validation and Verification documentation.
• Develop quality documentation such as quality plans, SOPs, and inspection procedures; ensure FDA/ISO compliance.
• Represent Quality initiatives during Design and Phase reviews.
• Identify industry best practices and lead quality disciplines and decisions.
• Ensure product requirements are documented in PR specs and verify via quarterly gap analyses.
• Apply statistically valid sampling techniques and teach others DOE/ANOVA and related methods.
• Review and approve PQs, TVs, GR&R, DOE, FMEA, CAPA, and master plans.
• Provide support for CAPA/NCRs/Complaint evaluations.
• Lead Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product testing and acceptance criteria.
• Apply systematic problem-solving to quality issues.
• Assist in special projects as needed.
• Contribute to team effort by performing related duties.

Skills

Quality engineering

DOE

GR&R

FMEA

CAPA

Process validation

FDA 21 CFR 820

ISO 13485

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Job description

ECI seeks a Senior Quality Engineer to enhance production processes with cross-functional collaboration, ensuring efficiency, quality, and safety. You will support QS integration, maintain compliance matrices, and contribute to Design Assurance activities including DV, DVAL and Usability.

You will review change requests, develop quality docs, and lead quality initiatives across product and process reviews in a regulated medical-device environment.