Quality Engineer — Process Excellence & Compliance

Tegra Medical; Dartmouth (MA); On-site; USD 84,000 - 105,000; Full time

Job summary

T Tegra Medical is seeking a Quality Engineer to lead quality initiatives and ensure processes align with the company’s quality vision. The role requires independent work and collaboration with Quality and Operations teams to improve products and processes.

The candidate will support GMP, FDA, and ISO 13485 standards, manage CAPA, supplier quality, and process validations, and drive continuous improvement in a fast-paced manufacturing environment.

Qualifications

• B.S. in engineering (or equivalent) is required; 5 years in Quality Engineering preferred.
• ASQ CQE/CQA preferred; Lean Six Sigma training desired.
• Strong engineering skills and problem analysis abilities are essential.
• Familiarity with GMP, FDA regulations (21 CFR 820) and ISO 13485 is expected.

Responsibilities

• Develop and implement quality policies and procedures for QMS.
• Lead investigations of internal and supplier quality issues and CAPA.
• Oversee qualifications/validations (IQ/OQ/PQ) for processes and products.
• Manage supplier change notifications with external manufacturers.
• Collaborate with Supply Chain, R&D, Operations to reduce process variability and drive improvement.
• Define and monitor metrics and KPIs for quality and process compliance.
• Provide engineering support for in-process and incoming inspections.
• Update specifications based on process improvements and quality data.

Skills

Problem solving

Communication skills

Quality engineering

Risk analysis

Process validation

Education

B.S. in engineering

Associates degree + 5 years experience

Tools

Minitab

Microsoft Office

MS Project

Job description

T Tegra Medical is seeking a Quality Engineer to lead quality initiatives and ensure processes align with the company’s quality vision. The role requires independent work and collaboration with Quality and Operations teams to improve products and processes.

The candidate will support GMP, FDA, and ISO 13485 standards, manage CAPA, supplier quality, and process validations, and drive continuous improvement in a fast-paced manufacturing environment.