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Quality Engineer I - Product Support - Memphis, TN

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  • Job
    Full-time
    Entry & Junior Level
  • Product
    Engineering
  • Memphis

Requirements

  • Education:
  • B.S. Engineering or related field required
  • Experience:
  • 0 -2 years related experience in medical device and or manufacturing preferred
  • Knowledge of statistics preferred
  • Experience/knowledge of applicable standards and regulations preferred.
  • Strong computer, scientific, and organizational skills
  • Excellent communication (oral and written) and attention to detail
  • Strong planning, organizational, critical thinking, and problem-solving skills
  • Ability to work independently with little to no supervision and as part of a team. Self-motivated, adaptable, and have a positive attitude.
  • Ability to learn new techniques quickly, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Must be skilled in the use of Microsoft Office products including Word, Excel, and PowerPoint
  • Persistent, driven, self-motivated, keen to make an impact
  • Excellent organizational, documentation and written/verbal communication skills
  • Physical Demands: Minor Physical Demands
  • Travel Requirements: <5%

Responsibilities

  • Supports new product development and implementation via the project quality plans, which may include needed inspection, test, and audit procedures; assisting with identification of needed reliability testing, storage stability testing, biological testing, sterilization adoptions; identification and procurement of needed gauges, equipment, etc.; and support of process/product validation. Works with PD team to perform design control activities for product revisions and line extensions. Tasks include, but are not limited too: risk assessments, test plan review, gaging and measurement studies, process verification and validation.
  • Participates in the post market surveillance process and coordinates monthly PMS trend reviews as assigned.
  • Develops and works with area teams to implement continuous quality improvement programs which may include: vendor certification for ship to stock; design of experiments to identify and thus control process variables; elimination of lot inspection and initiation of process audit activities; and installation of statistical and non-statistical process controls

FAQs

What are the main responsibilities of a Quality Engineer I - Product Support at Smith & Nephew in Memphis, TN?

The main responsibilities include supporting the Quality Management Systems, ensuring compliance with Regulations, Standards, and Guidelines, and ensuring finished devices are safe and effective in accordance with the Federal Food, Drug, and Cosmetic Act.

What qualifications are required for the position of Quality Engineer I at Smith & Nephew in Memphis, TN?

Qualifications for this position typically include a bachelor's degree in engineering or a related field, knowledge of quality management systems, experience in the medical device industry, and strong attention to detail.

What specific regulations and standards must a Quality Engineer I - Product Support adhere to in this role?

A Quality Engineer I must ensure compliance with regulations such as the Federal Food, Drug, and Cosmetic Act, as well as industry standards and guidelines to ensure the safety and effectiveness of finished medical devices.

How does a Quality Engineer I - Product Support contribute to the overall quality of Smith & Nephew products?

A Quality Engineer I plays a crucial role in ensuring that Smith & Nephew products meet all regulatory requirements and industry standards, ultimately ensuring that finished devices are safe and effective for use by patients.

We design and manufacture technology that takes the limits off living.

Manufacturing & Electronics
Industry
10,001+
Employees
1856
Founded Year

Mission & Purpose

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude, we work together to win.. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. Please note: not all products referred to may be approved for use or available in all markets.