Quality Engineer

Overview

We are seeking a proactive and technically strong Quality Engineer to support a fast-paced and highly collaborative product development environment. This role offers the opportunity to work across a wide range of quality and manufacturing activities, contributing directly to product development, process optimization, and commercialization efforts.

Key Responsibilities

• Support integrated development and engineering (IDE) builds, repair activities, and clinical build initiatives
• Contribute to De Novo program support and regulatory-related quality efforts
• Participate in design transfer activities, including execution and documentation
• Manage and support nonconformance investigations and resolution activities
• Lead and contribute to Process FMEA development and updates
• Develop, review, and maintain manufacturing and quality documentation
• Drive process improvements and continuous improvement initiatives
• Support process qualification activities, including protocol development and report generation
• Participate in design reviews, residual risk assessments, and lifecycle documentation updates
• Collaborate cross-functionally to identify issues, bring together key stakeholders, and help drive effective solutions

Qualifications

• Strong understanding of Quality Management Systems (QMS) within a regulated environment
• Demonstrated ability to quickly learn complex products, subassemblies, and manufacturing processes
• Proven technical capability in quality engineering, manufacturing support, or a related field
• Experience supporting process qualification, FMEAs, and nonconformance activities
• Able to work independently with minimal oversight while managing multiple priorities
• Strong collaboration and problem-solving skills, with the ability to engage cross-functional teams

Preferred Skills

• Experience in medical device or highly regulated industries
• Exposure to design transfer, clinical builds, or regulatory submission support
• Familiarity with risk management processes (e.g., FMEA, hazard analysis)
• Experience supporting products through development and commercialization phases

What Sets You Apart

• Proactive mindset with a willingness to step into unfamiliar areas and learn quickly
• Strong technical foundation paired with hands-on execution
• Ability to contribute meaningfully across a broad range of quality initiatives
• Effective communicator who can present ideas clearly and grow influence with stakeholders at all levels

Growth Opportunity

This role provides significant exposure across nearly all aspects of quality engineering within a product lifecycle. You will have the opportunity to deepen your expertise in areas such as process qualification, risk management, and cross-functional leadership, while expanding your visibility and impact within the organization.