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Sr Quality Engineer at Medtronic in North Haven, Connecticut

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Full-Time





Job Description:


Careers that Change Lives

MITG

The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. (PICK ONE BU IF APPLICABLE)

SURGICAL INNOVATIONS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

A Day in the Life

The Senior Quality Engineer is responsible for a supporting and maintaining Quality System, managing/analyzing customer complaints, conducting internal and external audits, and participates in New Product Development to assure quality considerations are adequately covered in the design, testing, and release of materials, components, and products.

POSITION RESPONSIBILITIES:




  • Supports and maintains the quality system and is able to make quality system recommendations and follow through to implementation to address issues found.

  • Work with other departments to resolve issues related to material and process quality, including FMEA, DOE.


  • Suggests recommendations on quality concerns, trends and costs.


  • Perform Validations (IQ, OQ, PQ, MSA, CQ) in accordance with company SOP's.

  • Ability to manage the customer complaint system. Performs analysis of customer complaints.


  • Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally.


  • Follow up on CAR effectiveness.


  • Schedules and conducts and/or coordinates internal and external audits; prepares and issues summarized reports; maintains quality surveillance of suppliers. Interface with supplier quality representatives concerning problems with quality and assure that effective corrective action is implemented.


  • Participates in New Product Development to assure quality considerations are adequately covered in the design, testing, and release of materials, components, and products.


  • Analyzes causes of defects and recommends or leads teams who recommend corrective actions.


  • May supervise and schedule work of Quality personnel and/or other subordinates as assigned.


  • Design methods for evaluating product quality; establishes test programs to evaluate materials, processes and products. Collect, analyze and interpret statistical data.


  • Develop Control Plans, Inspection Instructions and other documents as needed to effectively manage product/process quality.


  • Work with QA Technicians to resolve measurement, blueprint/specification issues.


  • Develop and review documented operating procedures associated with material inspection or processes.


  • Other duties as assigned by supervision.


Must Have: Minimum Requirements


  • Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality


  • OR Advanced Degree Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.


Nice to Have


  • Five - seven (5-7) years Quality experience in manufacturing.


  • Experience performing validations (IQ, OQ, PQ, MSA, CQ)


  • Experience in FDA regulated industry, helpful


  • Effective analytical, technical, and problem solving skills.


  • Effective planning and organizational skills.


  • Effective verbal presentation skills to small and/or medium sized groups.


  • Demonstrated ability to manage projects and multiple priorities.


  • Demonstrated knowledge and ability to use common software tools for spreadsheet, word processing, and presentation tasks.


About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)