Agile Programming Methodologies, American Society for Quality (ASQ), Analysis Skills, Atlassian JIRA, Biomedical Engineering, Business Processes, Certified Quality Engineer (CQE), Communication Skills, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Detail Oriented, Electricity, Fitness, Gap Analysis, Geometric Dimensioning and Tolerancing, Industrial Engineering, LinkedIn, Maintain Compliance, Manufacturing, Manufacturing Engineering, Metrology, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Validation, Product Design, Product Development, Product/Service Launch, Production Support, Production Systems, Purchasing/Procurement, Quality Control, Quality Engineering, Regulations, Requirements Management, Six Sigma Black Belt, Six Sigma Green Belt, Software Development, Software Testing, Statistics Software, Stock Purchase Plans, Technical Drawing, Test Case, Trend Analysis, Writing Skills
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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Smith & Nephew Plc
The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business.
Thomas James Smith black and white photograph
Image: Thomas James Smith
A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months.
By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments.
In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics — which offered high growth and margin opportunities.
Smith & Nephew was incorporated and listed on the London Stock Exchange in 1937 and in 1999 the Group was also listed on the New York Stock Exchange.
In 2001, Smith & Nephew became a constituent member of the FTSE-100 index in the UK. This means that Smith & Nephew is included in the top 100 companies traded on the London Stock Exchange measured in terms of market capitalisation.
Today, Smith & Nephew is a public limited company incorporated and headquartered in the UK and doing business in many countries around the world.