Medical Device Quality Engineer

Job Description

Join our dynamic and innovative medical device company, where we are dedicated to improving patient outcomes through cutting-edge technology and exceptional quality standards. We are seeking a highly skilled and motivated Quality Engineer to contribute to our mission of delivering life-changing medical devices.

Responsibilities

• Ensure compliance with relevant standards and 21CFR820.
• Lead Corrective and Preventive Action (CAPA) teams and cross-functional teams to address quality issues and implement effective solutions.
• Maintain and improve the Quality Management System (QMS) in accordance with regulatory requirements.
• Collaborate with cross-functional teams to support product development and ensure quality throughout the product lifecycle.
• Conduct internal audits and support external audits to ensure compliance with regulatory standards.
• Manage nonconformance reports and oversee the change control process, including review of validation/verification reports.
• Complete thorough complaint investigations and implement corrective actions as needed.

Essential Skills

• Proven experience in the medical device industry.
• In-depth knowledge of relevant standards and 21CFR820.
• Familiarity with MDSAP, EU MDD/MDR is highly preferred.
• Minimum of 5 years of experience working within a Quality Management System.
• Demonstrated experience leading CAPA teams and cross-functional teams.

Additional Skills & Qualifications

• Experience working with nonconformance reports.
• Experience with change control, including review of validation/verification reports.
• Experience completing complaint investigations.
• Internal auditing experience.
• New product development experience, with an understanding of the full design lifecycle and its relation to risk management.

Work Environment

Work Monday to Friday from 8 AM to 5 PM (flexible). This position requires onsite work at a brand new, clean, and high-tech facility. Join a forward-thinking company that values innovation and quality, and work in a collaborative and supportive environment.

Pay and Benefits

The pay range for this position is $50.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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)

Workplace Type

This is a fully onsite position in Raleigh,NC.

Application Deadline

This position is anticipated to close on Mar 7, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company 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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50 - $55