Quality Engineer II

Overview

Job Title: Quality Engineer II – Medical Device

Job Location: North Haven, Connecticut (Fully Onsite)

Type: W2 contract

Duration: 24 Months

• The duties related to the Quality Engineer II role require knowledge and experience in Medical Device industry to support or perform risk assessments, design change quality reviews, and support potential product quality issues in 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 approval of technical documentations related to engineering changes, perform root cause investigations, reviewing risk management files, ensure quality standards for patients and business unit goals are met.

• technical writing
• data analysis
• project management

Education Required / Years’ Experience

Required:

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

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.

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. Most of the 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).

Required Knowledge and

Experience:

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