$74,250–$111,500 Per Year
Analysis Skills, Biomedicine, Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Data Analysis, FDA (Food and Drug Administration), Fitness, ISO (International Organization for Standardization), LinkedIn, Manufacturing, Manufacturing Operations, Mechanical Engineering, Mentoring, Problem Solving Skills, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Quality, Process Validation, Product Support, Quality Engineering, Quality Metrics, Regulations, Regulatory Compliance, Risk, Risk Management, Root Cause Analysis, Statistics, Stock Purchase Plans, Systems Analysis, Team Player
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Are you passionate about driving quality excellence in a fast-paced manufacturing environment? As a Manufacturing Quality Engineer II, you will play a key role in ensuring our products meet the highest standards of compliance and performance, while contributing to continuous improvement initiatives that directly impact patient outcomes. This is an exciting opportunity to grow your career in a collaborative and purpose driven environment where your expertise truly makes a difference.
What will you be doing?
- Supporting and improving product and process quality across manufacturing operations
- Leading and supporting nonconformance investigations and CAPA activities, including root cause analysis and implementation of corrective actions
- Partnering with manufacturing and operations teams to strengthen process robustness and reduce variation and defects
- Applying risk-based thinking using tools such as PFMEA to identify and mitigate process risks
- Developing and optimizing inspection strategies, including measurement system analysis
- Performing data analysis using statistical tools such as control charts and capability analysis
- Supporting process validation activities including IQ, OQ, and PQ
What will you need to be successful?
Education:
- Bachelor's degree in Engineering such as Mechanical, Biomedical, Industrial, or a related discipline
Experience:
- 1 to 3 years of experience in quality engineering within a manufacturing environment
- Experience working in a regulated industry
Knowledge:
- Strong understanding of quality standards and regulations including ISO 13485 and FDA 21 CFR Part 820
- Ability to apply statistical analysis and quality engineering principles to solve problems and drive improvements
The anticipated base compensation range for this position is $74,250 - $111,500 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.
In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.
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/Vacation Time Off, 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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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.
2,000 to 2,499 employees
Medical Devices and Supplies