Quality Engineer II - Exempt

Join our team in Fort Worth, TX, where you'll be at the forefront of ensuring top-notch quality in our products and processes. This is a fantastic opportunity to work onsite with a dynamic team dedicated to excellence in the medical device industry.

• CAPA management
• Conduct Root Cause Investigation Analysis
• NCMR disposition
• Senior Quality Engineering - Consultant

• Experience with Medical Device or another highly regulated industry
• Experience in Problem Solving / Lean Six Sigma
• Experience in Statistical Methods or Data Analysis
• Experience in Process Validation
• High attention to detail and accuracy
• Effective English verbal and written technical communication and presentation skills
• ASQ CQE, CQA certification is a plus

• Problem Solving/ Root Cause Investigation/ CAPA Management
• Process Validation (including Test Method Validation)
• Six Sigma

Responsibilities may include the following and other duties may be assigned:

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of 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 may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

• 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: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of 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 Support Career Stream.

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.

This position requires the candidate to work onsite 5 days a week, 40 hours per week. No remote work is available.