Quality Engineer I - Exempt

Quality Engineer

We are seeking a dedicated and detail-oriented Quality Engineer to join our team. This role involves ensuring our manufacturing processes meet the highest quality standards, particularly in tubing extrusion manufacturing and the production of Percutaneous Transluminal Angioplasty (PTA) Balloon Catheters.

Key Skills Required

• Attention to Detail
• Root Cause Analysis
• Process Validation

Main Responsibilities

• Support day-to-day manufacturing from a quality perspective.
• Investigate nonconformances and implement corrective measures.
• Conduct process validation for new equipment and yield improvement projects.

Products Supported

• Tubing extrusion manufacturing
• Percutaneous Transluminal Angioplasty (PTA) Balloon Catheters

Responsibilities

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

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished product.
• 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 the cost of and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure 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.

Technical Specialist Career Stream

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, 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 R&D, systems, or initiatives related to new technologies or therapies from design to implementation while adhering to policies, using specialized knowledge and skills.

Differentiating Factors

• Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
• Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
• Innovation and Complexity: Identifies, defines, and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
• Communication and Influence: Communicates primarily with internal contacts within the immediate group. Contacts others to gather, confirm, and convey information.
• Leadership and Talent Management: N/A job at this level is focused on self-development.
• Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A)), 0 years of experience required.