Quality Engineer I

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living. As a Quality Engineer, you'll play a critical role in ensuring our product integrity and driving continuous improvement in a fast-paced, production environment. This position offers the opportunity to apply your technical expertise to campus-wide digitization initiatives as we transition our business to Industry 4.0/5.0. Prospective candidates must have an eagerness to learn, foundational understanding of cGMP, strong communication skills, and keen attention to detail.

What will you be doing?

• The Quality Engineer will report to the Operations Quality Engineering Team. This role works cross-functionally with other departments to support daily production targets, transformational projects, and continuous improvement initiatives. This role is responsible for maintaining compliance to internal and external standards and regulations, both within the QMS and on the production floor.
• Coordinates and leads countermeasure meetings to review processes, perform gap analyses, and implement new technologies.
• Works with cross-functional teams in the resolution of quality problems, which may involve processing of NCRs, CAPAs, material dispositions, data trending and analysis, and presentation to internal customers and external vendors.
• Develops, documents, and implements various inspection techniques and procedures to ensure product integrity to design specifications.
• Coordinates with other Engineers and Metrology personnel on the review, design, development, and procurement of product gauging.
• Coordinates development and implementation of digitized processes, which may include writing work instructions, app development, and case testing.
• Trains Manufacturing and Quality Control associates on business processes and inspection techniques.
• Works with Manufacturing Engineers to perform first article inspections, capability studies, validations (IQ, OQ, PQ), and engineering analyses to characterize products, processes, and materials.
• Coordinates with Design Quality and Product Development on new product introductions, including the evaluation of critical features and proposed inspection techniques.

What will you need to be successful?

• Education: Bachelor of Science in Mechanical, Manufacturing, Electrical, Biomedical, Industrial Engineering, or equivalent technical discipline required.

• Licenses/Certifications: ASQ CQE and Six Sigma Green or Black Belt preferred.

• Experience: 0-3 years in a quality, engineering, or manufacturing role preferred.

• Foundational understanding of cGMP and quality systems in a regulated industry

• Strong analytical and problem solving skills with experience in data analysis and root cause methodologies

• Ability to read and interpret technical drawings, specifications, and GD&T

• Clear written and verbal communication skills with the ability to present to cross functional audiences

• Experience with statistical tools, software development, or digital manufacturing platforms preferred

• Familiarity with Tulip, Jira, and Agile methodologies preferred

• Ability to stand or sit for extended periods and perform hands on measurement using basic inspection tool

• Physical: Ability to measure product using simple hand instruments, stand, or sit for extended periods.

• Physical: Vision must be excellent or corrected.

• Travel: 0-10%

You. Unlimited.

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

Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement

Work/Life Balance: Flexible Personal and Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

Your Wellbeing: Medical, Dental, Vision, Health Savings Account with Employer Contribution, 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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