Quality Engineer II - Exempt

Join our team in Warsaw, IN, a thriving hub for medical device innovation, where you can grow your career as a Quality Engineer II. This role offers a unique opportunity to work in a dynamic environment focused on EU MDR Compliance. Top 3 Technical Skills Required for the Role:

• Exposure to or knowledge of EU MDR compliance
• Effective collaboration with cross-functional teams
• Ability to work independently with general supervision on a larger project/assignment

Education and Experience Required:

• Bachelor's degree
• 3 years of relevant experience

Work Schedule:The contractor will be working 40 hours a week onsite. Responsibilities:

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• 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 and equipment;conduct quality assurance tests;and perform statistical analysis to assess costs and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Specialist Career Stream:

• Typically an individual contributor with responsibility in a professional discipline or specialty.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or direct the work of other lower-level professionals.
• The majority of time is spent delivering and overseeing projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Differentiating Factors:Autonomy:

• Established and productive individual contributor.
• Works independently with general supervision on larger, moderately complex projects/assignments.

Organizational Impact:

• Sets objectives for own job area to meet the objectives of projects and assignments.
• Contributes to the completion of project milestones.
• May have some involvement in cross-functional assignments.

Innovation and Complexity:

• Faces general problems and issues that may require understanding of a broader set of issues or other job areas but are typically not complex.
• Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of the job area.

Communication and Influence:

• Communicates primarily and frequently with internal contacts.
• External interactions are less complex or problem-solving in nature.
• Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.

Leadership and Talent Management:

• May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience:

• Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience.
• Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.