Quality Engineer I - Product Support (Memphis, TN)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Quality Engineer I is responsible for supporting the Smith & Nephew Quality Management Systems. The Quality Engineer I will ensure that the Regulations, Standards and Guidelines are complied with ensuring that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).

What will you be doing?

• 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;

What will you need to be successful?

• 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%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement

Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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