Job Title - Sr Quality Engineer - Exempt

Job Location -North Haven, Connecticut

Duration :- 12 Months

Job Description -

We are looking for a dynamic and adaptive Sr. Quality Engineer, with the desire to be part of the fast-growing Surgical Innovations business, helping us to ensure they exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

• This position provides reliability and quality engineering support on new development projects.
• The candidate will be a key player in cross-functional teams and serve as a compliance and technical representative for reliability, safety, and quality functions.
• As part of Quality project teams, the Sr. Quality Engineer will define, contribute, and execute the quality plan for ensuring compliance to regulatory requirements.
• This position will collaborate with multidisciplinary teams and provide guidance to technical issues, engagement in design and risk reviews, and contribute to development activities.

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

• The Senior Quality Engineer position on the team supports new product development for various product families in the Surgical Innovations Business.
• In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team.
• An understanding of Reliability Engineering combined with Defect/Issue Management, Reliability Test Method Development/Setup/Analysis, Reliability Demonstration Analysis, Develop/Conduct Reliability studies and evaluations, Mechanical and Electro-Mechanical Design, Design Failure Modes and Effects Analysis, Design Verification, Design Validation, process validation, Reliability (Planning, Allocation, Modeling, Prediction, Strategy, Assessment), Reliability Test Development, Electromagnetic Compatibility (EMC) Requirements/Testing/Development, Risk Management process per ISO 14971 is preferred.
• As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.

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 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.