Quality Engineer - Exempt

Position: Quality Engineer I - Exempt

Join our dynamic team in North Haven, CT, where you will have the opportunity to work on-site at least four days a week. This location offers a vibrant community and is a hub for innovation in healthcare technology.

Project Overview

Contribute to the New Product Development (NPD) Quality team, focusing on the development of Risk Management files and Design History files for new surgical products.

Team Composition

Be part of a collaborative team of 16 Quality Engineers, ranging from Principal to QEII, working together to ensure the highest quality standards.

Key Responsibilities

• Create and maintain Risk Management files for new products, including Preliminary Hazard Analysis (PHA) and Risk Analysis Chart (RAC) creation.
• Develop Design Failure Mode and Effects Criticality Analysis (DFMECA).
• Support Design Validation and Design Verification activities.
• Conduct Complaint Analysis, Prediction, and Review.
• Engage in Reliability Assessment and Planning.

Required Skills and Attributes

• Entry-level position with 0-2 years of experience.
• Engineering degree required.
• Experience supporting R&D, NPD, or Quality is valuable.

Preferred Skills and Attributes

• Experience in Reliability Planning/Testing or Risk Management is a plus.

Interview Process

• One round of interviews conducted via video.
• Interviews will focus on entry-level technical knowledge.

Responsibilities and Duties

• Develop, modify, apply, and maintain quality standards and protocols for processing materials.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating product precision and accuracy.
• Design or specify inspection and testing mechanisms and equipment.
• Conduct quality assurance tests and perform statistical analysis.
• Ensure corrective measures meet reliability standards and documentation is compliant.

Technical Specialist Career Stream

As an individual contributor, you will advance existing technology or introduce new technology and therapies. You will manage projects, collaborate with stakeholders, and may act as a mentor to colleagues. The focus is on delivering R&D systems or initiatives related to new technologies or therapies, from design to implementation, while adhering to policies and utilizing specialized knowledge and skills.

Differentiating Factors

• Autonomy: Entry-level individual contributor with close supervision.
• Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects.
• Innovation and Complexity: Identifies and addresses problems that are not immediately evident but typically not difficult or complex.
• Communication and Influence: Communicates primarily with internal contacts within the immediate group.
• Leadership and Talent Management: Focused on self-development.

Required Knowledge and Experience

Requires broad theoretical job knowledge typically obtained through advanced education. A Baccalaureate degree is required, with 0 years of experience necessary.

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