Sr. Engineer, Qa (Medtech)

TL;DR

Sr. Engineer, QA (Medtech): Providing senior-level quality assurance support and oversight to Corrective and Preventive Action (CAPA) activities within the Quality Compliance department with an accent on effective and timely CAPAs. Focus on facilitating investigations, root cause analyses, and leading continuous improvement activities.

Location: Merrimack, NH, US. Hybrid office environment with 1-2 days at home (site-based).

Salary: $95K-120K with 10% STIP

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

• Provide senior-level quality assurance support and oversight to CAPA activities to ensure effective and timely CAPAs.
• Guide cross-functional teams through the CAPA request/CAPA process and facilitate activities.
• Facilitate investigations and root cause analyses to appropriately address underlying issues.
• Perform CAPA Verification of Implementation and Effectiveness Check activities and process CAPA documentation within the electronic systems.
• Lead continuous improvement activities within the CAPA process and develop and perform CAPA System training.
• Support external audits and prepare documentation needed to fulfill requests from customers.

Requirements

• Bachelor’s degree in engineering or scientific discipline or equivalent experience.
• Minimum 3 years’ experience with CAPA and root cause investigations.
• Minimum 3 years’ quality experience in the medical device industry or other highly regulated industry.
• Strong communication and organizational skills with a high level of attention to detail and accuracy.
• Knowledge of Quality Systems, ISO 13485 and FDA requirements.
• Strong computer skills, including MS Office applications and statistical software.

Culture & Benefits

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