Quality Engineer II - Exempt

The duties related to this role require knowledge and experience in the Medical Device industry to support or perform risk assessments, design change quality reviews, and support potential product quality issues in the released product portfolio. This encompasses all aspects of a medical device’s lifecycle such as design, manufacturing, distribution, and obsolescence. The diversity of duties and skills may include technical writing (Design Failure Mode Effect Analysis, and other related technical documentation) to creative and critical thinking, working with diverse teams in resolving quality issues and process improvements. The duties are complex as, depending on the complexity of the issues, all duties and projects are often performed in parallel.

The products that the employee will work on support the Core Surgical Innovations (CSI) Stapling product portfolio within the Medical Surgical operating unit. Knowledge in understanding product design helps to assess risks associated with the product and ensure product reliability standards are met.

The employee’s work will have an immediate impact on the CSI product Stapling portfolio and business performance, as there are significant continuous improvement projects, product/process changes to be implemented to fulfill the market requirements. Extensive work associated with performing product quality assessments, reviewing and approving technical documentation related to engineering changes, performing root cause investigations, reviewing risk management files, and ensuring quality standards for patients and business unit goals are met.

Top 3 Technical Skills Required for the Role:

• Technical writing
• Data analysis
• Project management

Education and Experience Required:

Baccalaureate degree and a minimum of 2 years of relevant experience OR a Master's degree with a minimum of 0 years of relevant experience.

Work Schedule:

40 hours per week, hybrid schedule with 4 days minimum on-site required and 1 day remote allowed.

Responsibilities:

• Develops, modifies, applies, and maintains quality standards and protocols 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.

Location:

Join our team in North Haven, CT, a vibrant community offering a great quality of life, with proximity to cultural and recreational activities. This location provides an excellent environment for professional growth and development.