Engineer II, QA (Medtech)

TL;DR

Engineer II, QA (Medtech): Providing Quality Assurance support and oversight to Corrective and Preventive Action (CAPA) activities with an accent on regulatory compliance and failure investigations. Focus on leading root cause analyses, managing CAPA timelines, and ensuring effectiveness checks are performed.

Location: Hybrid (Merrimack, NH, US)

Salary: $90,000–$110,000

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Lead CAPA Request and CAPA teams through the full process for successful completion.
• Provide project management support to ensure timelines are agreed upon and met.
• Drive problem definition, scoping, and facilitate failure investigations and root cause analyses.
• Review documentation to ensure compliance with procedures and regulations.
• Perform CAPA verification of implementation and verification of effectiveness activities.
• Prepare documentation for trending and metrics using MS Office.

Requirements

• Bachelor’s degree in an engineering or scientific discipline (e.g., Chemistry, Biology, Physics).
• 2+ years of quality experience in the medical device industry or other highly regulated industry.
• Proven experience performing root cause investigations.
• Knowledge of Quality Systems, ISO 13485, and FDA requirements.
• Ability to manage cross-functional projects and prioritize key deliverables.
• Proficiency in MS Office applications (Word, Excel, PowerPoint).

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off.
• Wellness initiatives and Health Assistance Resources.
• Tuition Reimbursement.
• Parental and Caregiver Leave.