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Minneapolis, Minnesota - USD Full Time Posted: Friday, 10 August 2018
TE s Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world s leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.
Job Overview
The Senior Quality Engineer is a member of the Operations Quality group. This role is responsible for Operations Quality within their prescribed area of functional responsibility. The Senior Quality Engineer will be working as part of a value stream team to maintain high quality/performance standards on all Creganna Medical products. As required, they will lead cross-functional teams to support resolution of product and/or process related issues or objectives. This challenging position will require an ability to work with minimum supervision, pursue continuous improvement, and ensure compliance to the Creganna Medical Quality System. The Senior Quality Engineer is responsible for establishing, implementing and maintaining systems and/or services to measure and improve product quality, cost, and customer service while ensuring full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements.
  • Overall responsibility for production GMP standards and compliance.
  • Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
  • Establishing inspection standards, plans, frequencies and test methods.
  • Establishing and maintaining FMEA s.
  • Preparing and updating Operations procedures and associated documentation.
  • Reporting area of responsibility metrics.
  • Supporting customer and surveillance accreditation audits.
  • The Senior Quality Engineer will perform an active role in quality planning and new product introduction from a quality perspective.
  • The associate will have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Develop strong links with customer organisation s and other project stakeholders.
  • Quality review of responsible area validation documentation.
  • Performing an active role in further development and continuous improvement of the quality management system.
  • Will assist in issues related to Metrology, Inspection, Testing, Product stability, and vendor certification programs.
  • Will lead and manage the Material Board to ensure products are appropriately dispositioned within a timely
  • requirements are met.
  • Participates as a key member of new product development core teams, to help ensure that new product quality plans (validation plans, raw/component material specifications, etc.) and risk management files are appropriately established.
  • Will assist and train associates in concepts of probability and statistics.
  • Design and develop forms and instructions for recording, evaluating, and reporting quality data.
  • Investigate and implement corrective and preventive actions (CAPAs) to meet business and compliance requirements.
  • Based on operational/quality requirements, provide test equipment selection and validation.
  • Utilize formal problem-solving techniques to resolve product and/or process related issues.
  • Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.
  • Perform Supplier Quality Audits as necessary.
  • Assist with the development and maintenance of the company-wide validation programs.
  • Reports verbally and in writing to the Director/Manager regarding the progress and results of projects. Participates with the Director/Manager in the preparation of divisional, departmental, and project goals. Assists the Director/Manager in presentations of technical nature when requested.
  • The Senior Quality Engineer shall be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as EN46001/ISO13485/MDD Standards.
  • Will assist in Lean Manufacturing and be supportive in TEOA projects and initiatives i. e. Kaizen, CFPS, etc.
  • Other duties as assigned from time to time.
  • BS/BA degree with a scientific emphasis required
  • Min. 5 years' experience as quality engineer
  • ASQ Certified Quality Engineer preferred
  • Six Sigma Green/Black belt preferred
  • Quality experience in component and device manufacturing preferred.
  • Excellent written and oral communication skills essential.
  • Values: Integrity, Accountability,Teamwork, Innovation

Minneapolis, Minnesota, United States of America
TE Connectivity
TE Connectivity
8/10/2018 2:28:58 PM

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