Quality Systems Engineer: CAPA & Process Improvement

DEKA Research & Development; Manchester (NH); On-site; USD 70,000 - 90,000; Full time

Job summary

DEKA Research & Development in Manchester, NH is looking for a Quality Systems Engineer to ensure the highest standards in quality and compliance. This role involves managing the CAPA process, facilitating cross-functional teams, and maintaining compliance with FDA 21 CFR Part 820 and ISO 13485.

Ideal candidates will have a BS/MS in Engineering or Life Sciences and at least 3 years of quality systems experience in regulated environments, particularly in medical devices. Strong communication and technical writing skills are essential for this role, which offers the chance to make a significant impact on innovative products.

Qualifications

• 3+ years of experience in a quality systems role in a regulated industry, ideally medical devices.
• Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
• Proficiency with Microsoft Office suite.

Responsibilities

• Manage the end-to-end CAPA process ensuring quality compliance.
• Facilitate cross-functional CAPA review meetings.
• Develop and revise Standard Operating Procedures (SOPs).
• Conduct internal audits and support external audits.

Skills

Technical writing

Project coordination

Problem-solving

Verbal communication

Attention to detail

Education

BS/MS in Engineering, Life Sciences, or a related field

Tools

Microsoft Excel

Microsoft Word

Microsoft Visio

Job description

DEKA Research & Development in Manchester, NH is looking for a Quality Systems Engineer to ensure the highest standards in quality and compliance. This role involves managing the CAPA process, facilitating cross-functional teams, and maintaining compliance with FDA 21 CFR Part 820 and ISO 13485.

Ideal candidates will have a BS/MS in Engineering or Life Sciences and at least 3 years of quality systems experience in regulated environments, particularly in medical devices. Strong communication and technical writing skills are essential for this role, which offers the chance to make a significant impact on innovative products.