Quality Engineer II - Exempt

The Quality Engineer II will support a major initiative focused on EU MDR compliance, ensuring that products and processes meet rigorous regulatory and quality standards. This role develops, applies, and maintains quality standards and protocols for processing materials into partially finished or finished products, while collaborating closely with engineering and manufacturing teams. The position suits an established individual contributor who can work independently with general supervision on moderately complex projects and contribute meaningfully to cross-functional initiatives.

Responsibilities

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing teams to ensure appropriate quality standards are defined, implemented, and maintained across processes and products.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms, tools, and equipment to verify product quality and process capability.
• Conduct quality assurance tests and perform statistical analysis to assess product and process performance, including cost and responsibility for nonconforming products or materials.
• Identify, document, and analyze products or materials that do not meet required standards and specifications, and determine appropriate corrective and preventive actions.
• Ensure corrective measures meet acceptable reliability standards and that all related documentation complies with applicable requirements, including EU MDR.
• Contribute to or specialize in areas such as design quality, incoming material quality, production control, product evaluation and reliability, inventory control, or research and development as they relate to product or process quality.
• Deliver and manage assigned projects from design through implementation, ensuring adherence to internal policies, procedures, and regulatory requirements.
• Collaborate frequently with internal stakeholders to share status, needs, risks, and issues, and to gain input and support for decision-making.
• Provide guidance and assistance to entry-level professionals or support staff as needed, acting as a mentor and helping to develop their skills in quality engineering and compliance.
• Recommend and implement enhancements to systems, processes, and procedures to improve quality, efficiency, and overall effectiveness within the job area.
• Support general problem-solving activities that may require understanding of broader issues across different job areas, particularly in relation to EU MDR compliance and quality standards.

• Practical knowledge and demonstrated competence in quality engineering within a regulated environment.
• Exposure to or knowledge of EU MDR compliance requirements, particularly as they relate to medical devices.
• Ability to work independently with general supervision on larger, moderately complex projects and assignments.
• Proven experience in developing, implementing, and maintaining quality standards and protocols for materials and finished products.
• Experience devising and implementing inspection and test methods, including the design or specification of inspection and testing mechanisms and equipment.
• Ability to conduct quality assurance tests and perform statistical analysis to evaluate product and process performance.
• Strong collaboration skills with cross-functional teams, including engineering and manufacturing, to ensure quality standards are in place and maintained.
• Ability to identify nonconforming products or materials, determine root causes, and ensure effective corrective and preventive actions.
• Solid documentation skills to ensure that quality records and corrective actions comply with internal and regulatory requirements.
• Effective communication skills to share information, status, needs, and issues with internal stakeholders and to support decision-making.
• Bachelor’s degree (University Degree) in a relevant field.
• Approximately 3 years of relevant experience in quality engineering or a related discipline, or a combination of advanced education and experience.
• EU MDR-related experience in the medical device field.

• Advanced degree in a relevant discipline is beneficial and may offset years of required experience.
• Experience working on projects specifically focused on regulatory compliance, such as EU MDR initiatives.
• Familiarity with production control, product evaluation, reliability engineering, inventory control, or research and development as they relate to product or process quality.
• Experience mentoring or guiding entry-level professionals or support staff in a technical or quality-focused environment.
• Ability to recommend and implement improvements to systems and processes to enhance quality and operational effectiveness.
• Comfort working in a role that requires both independent contribution and collaboration across multiple functions.

This position operates in a professional, engineering and manufacturing-oriented environment that emphasizes regulatory compliance, particularly with EU MDR requirements. The role involves frequent interaction with cross-functional teams, including engineering, manufacturing, and quality functions, and requires regular use of quality tools, inspection and testing equipment, and standard office and collaboration technologies. Work is primarily project-based, with a focus on delivering initiatives from design through implementation while adhering to established policies and procedures. The environment supports independent work with general supervision, along with opportunities to contribute to cross-functional assignments and to mentor less experienced colleagues. Specific work hours, on-site versus remote expectations, and dress code follow standard professional practices and are defined by the employer’s internal policies.

Job Type & Location

This is a Contract position based out of Warsaw, IN.

The pay range for this position is $80.00 - $80.00/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)

This is a fully onsite position in Warsaw,IN.

This position is anticipated to close on May 1, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $80