Quality Engineer

Responsibilities

• Own and drive CAPA activities from initial investigation through root cause analysis, implementation of corrective and preventive actions, and formal closure.
• Manage and resolve Non-Conforming Material Reports (NCMRs), ensuring appropriate disposition and documentation.
• Support design quality efforts across the product lifecycle, with a primary focus on activities outside of manufacturing operations.
• Collaborate cross-functionally with Engineering, Regulatory, and Operations to investigate and resolve quality issues and ensure alignment on quality standards.
• Identify gaps in existing quality processes and proactively propose, develop, and implement improvements.
• Operate with a strong sense of urgency to ensure timely resolution of quality events and minimize impact on products and patients.
• Balance hands-on execution and effective delegation, while remaining directly involved in technical quality work as needed.
• Independently manage quality investigations and CAPA tasks with limited direction, maintaining high standards of documentation and compliance.
• Support both technical execution and process ownership for quality systems and initiatives.
• Contribute to building and refining quality processes in a fast-paced, evolving environment.

Requirements

• 2–6+ years of experience in Quality Engineering within medical devices or a regulated industry.
• Hands-on experience independently managing CAPAs and conducting quality investigations.
• Experience working with Non-Conforming Material Reports (NCMRs).
• Exposure to design quality principles, with focus not strictly limited to manufacturing or operations.
• Strong problem-solving skills and the ability to think critically through complex quality issues.
• Proven ability to work independently with limited direction while maintaining accountability for results.
• Excellent communication skills, with the ability to clearly convey technical information to cross-functional partners.
• Prior experience supporting both technical execution and ownership of quality processes.
• Motivation to build and improve quality processes in a growing, innovative organization.
• Interest in contributing to product quality and patient outcomes in a mission-driven setting.
• Ability to balance detailed technical work with broader process improvement initiatives.

Qualifications

• Eligibility for equity upon full-time conversion, subject to company policies.

Skills

• Experience working in a Contract Manufacturer (CMO) or small to mid-sized medical device company.
• Proven ability to work independently with limited direction while maintaining accountability for results.
• Excellent communication skills, with the ability to clearly convey technical information to cross-functional partners.
• Prior experience supporting both technical execution and ownership of quality processes.
• Motivation to build and improve quality processes in a growing, innovative organization.
• Interest in contributing to product quality and patient outcomes in a mission-driven setting.
• Ability to balance detailed technical work with broader process improvement initiatives.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Work Environment

• Based in a growing, innovative medical device environment that is fast-paced and evolving.
• Highly cross-functional setting with an emphasis on both technical quality execution and continuous process improvement.
• Team operates with core collaboration hours from 9:00 AM to 3:00 PM, offering flexibility outside of those hours to support work-life balance.
• Opportunity to grow into full-time opportunities and potentially participate in equity programs upon conversion.

About Actalent

• A global leader in engineering and sciences services and talent solutions.
• Helps visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.
• Network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe.
• Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.