Engineer 1, Quality Engineering

Supports continuous improvement initiatives by applying quality tools such as Lean, Six Sigma, Kaizen, and PDCA to enhance product quality, process efficiency, and cost effectiveness. Also benchmarks best practices and develops quality engineering capabilities to support business growth.
 

Ensures products and manufacturing processes comply with global regulatory requirements and quality standards. Supports audits, conducts production line assessments, and drives corrective and preventive actions to maintain compliance.
 

Works closely with R&D and cross-functional teams to support new product introductions and design transfers, ensuring appropriate design controls, risk management, and product quality requirements are met.
 

Leads material review activities and manages non-conformances, CAPAs, and customer complaints. Responsible for root cause investigations, quality metrics, defect management, and maintaining Device History Records (DHR) to ensure product quality and compliance.
 

Supports process validation and qualification activities, including IQ, OQ, PQ, TMV, and software validation. Develops control plans, sampling plans, measurement systems, and process monitoring methods to ensure process capability and product quality.
 

Evaluates process changes and quality risks to prevent non-compliance and product failures. Applies risk management principles to assess controls, implement mitigation measures, and ensure ongoing product safety and quality.
 

Develops and supports quality strategies for product, process, and test method validation. Participates in strategic initiatives and special projects assigned by management to support business objectives and continuous improvement efforts.

• This role leads sustaining quality performance and new product transfer activities, ensuring manufacturing processes are capable, validated, compliant, and effectively managed for risk. It requires strong cross-functional coordination to maintain production continuity, meet customer quality expectations, and deliver projects on time, with hands-on troubleshooting and sound technical decision-making.
• The ideal candidate has a Bachelor’s Degree in Engineering or a related technical field, with relevant manufacturing/operations experience. Strong knowledge of Lean, Six Sigma, SPC, MSA, DOE, Reliability, FDA/ISO risk management, GMP, NPI, and Process Validation is important, along with statistical data analysis, project leadership, and experience implementing effective risk-mitigation strategies in regulated environments.

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

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

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

Your Wellbeing: Medical, Dental, Vision, Health Savings Account , Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program  

Flexibility: Hybrid Work Model (For most professional roles)  

Training: Hands-On, Team-Customized, Mentorship