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Senior Quality Engineer - Product DevelopmentJob Description
Quality Engineer - Product Development, you will perform engineering design services and other related product development activities. You will partner with the project team and customer on topics related to safety agency and regulatory compliance as well as the necessary quality systems.
Responsibilities
Ensure that the planned project activities comply with Operating Procedures, applicable Quality Management System (certified under ISO 9001, AS9100), and applicable industry-specific regulations such as FDA, FCC, FAA, MDR, IVDR, REACH, RoHS, etc.
Provide strategy and direction for the development team on identifying and managing applicable industry-specific safety standards such as IEC standards.
Direct the development and assembly of prototypes by authoring and reviewing product documentation in accordance with quality and change management procedures and guidelines.
Demonstrate expertise in understanding of Quality Management System, required ISO 9001, and AS9100.
Determine appropriate specifications to comply with regulatory and compliance requirements of intended markets, and facilitate documentation of such specifications.
Assist project management in the development of proposals to ensure accurate technical, staffing, budgetary, and schedule content.
Communicate effectively with customers (internal and external) regarding project technical subject matter through teleconference, email, and in-person interactions.
Lead project teams through product risk management activities such as Hazard/Harm Analysis, Failure Mode and Effects Analysis, Fault Tree Analysis, and Cybersecurity risk assessments.
Essential Skills
Product Quality Engineering experience
Experience in regulated environments
Knowledge of ISO 9001 or AS9100
Product risk management experience
Understanding of product development processes
Familiarity with IEC standards
Additional Skills & Qualifications
Ability to work independently in multiple phases of the Product Realization Process
Strong communication skills
Experience with quality and change management procedures
Work Environment
The role requires working onsite. The work environment includes a high-performing engineering team with great retention, variety of work, and a positive company culture. The company operates within consumer products, aerospace, and medical device industries, delivering highly advanced capabilities for their customers
Pay and Benefits
The pay range for this position is $45.00 - $50.00/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 hybrid position in Raleigh,NC.
Application Deadline
This position is anticipated to close on Mar 28, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.