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

The Quality Engineer I is responsible for supporting quality assurance and quality control processes to ensure products and processes meet specified standards and customer expectations. This person will evaluate products, manufacturing processes, assembly processes, and supports quality control activities through training, inspection procedure preparation, and technical support. They also troubleshoot issues, provide technical guidance, and may collaborate with other departments to support production and quality assurance processes. This role requires strong technical knowledge in GD&T, effective communication, and attention to detail.

What will you be doing?

Product and Process Inspection:

Conduct inspections and tests on products, materials, and equipment to verify quality.

Check production processes for adherence to standards and identify any deviations.

Document and report any quality issues or defects found during inspections.

Data Collection and Analysis:

Collect and analyze data related to product quality and process performance.

Use statistical tools to track quality metrics and trends, such as defect rates or customer complaints.

Identify patterns or areas for improvement based on data analysis.

Documentation and Reporting:

Maintain records of inspection results, testing data, and quality reports.

Help create and update quality documentation, such as standard operating procedures (SOPs) and quality control plans.

Report quality issues to senior engineers or supervisors and help implement corrective actions.

Root Cause Analysis and Problem-Solving

Assist in identifying the root causes of quality issues and work with other teams to find solutions.

Participate in problem-solving efforts, such as failure mode and effects analysis (FMEA) or root cause analysis (RCA).

Implement corrective and preventive actions (CAPA) to reduce the likelihood of recurring issues.

Support for Audits and Compliance

Assist in internal and external audits to ensure compliance with quality standards, such as ISO 9001 and 13485, 21CFR, and/or industry-specific requirements.

Ensure products and processes comply with regulatory requirements and company policies.

Work with teams to address audit findings and implement improvements.

Collaboration and Communication

Work closely with production, engineering, and other teams to communicate quality standards and expectations.

Provide training or guidance to team members on quality procedures and best practices.

Help foster a culture of continuous improvement by supporting quality initiatives and projects.

Learning and Development

Stay updated on industry trends, quality standards, and best practices.

Participate in training and development programs to improve technical skills, knowledge, and career growth.

Supporting site CAPA process and owners to drive timely completion of CAPAs.

Data analysis and metrics reporting

Training, other project support, audit support, etc.

What will you need to be successful?

Education:

B.S. of Engineering or related experience in a technical field preferred.

Experience:

0 - 2 years related experience in medical device, quality control, and/or manufacturing preferred.

Professional certification such as ASQ Certified Calibration Technician (CCT) or ISO/IEC certification preferred.

Previous internship/Co-op related experience preferred.

Knowledge of statistics preferred                                                        

Experience/knowledge of QSR and ISO preferred

Experience in inspection procedures/methods preferred

Strong computer, scientific, and organizational skills

Excellent documentation and written/verbal communication skills

Strong planning, organizational, critical thinking, and problem-solving skills

Ability to work independently with some supervision as part of a cross-functional 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 align with company policies

Must be skilled in the use of Microsoft Office products including Word, Excel, and PowerPoint

Persistent, driven, not afraid to ask questions, keen to make an impact

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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