Senior Supplier Quality Engineer (Oklahoma City, OK)

Senior Supplier Quality Engineer (Oklahoma City, OK)

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

Among other activities, the Supplier Quality Engineer (SQE) 3 is primarily responsible for support and sustainment of robust Supplier Management programs for designated manufacturing and development activities. Emphasis will be on component suppliers, contract manufacturers and OEM suppliers who support activities that will ensure that products meet design and process specifications consistently. The SQE will be part of a global supplier quality engineering team to ensure purchasing controls meet ISO13485:2016 as well as specified international regulatory requirements. The SQE 3 is to ensure data driven decisions and proven processes are implemented and maintained by utilizing engineering techniques and tools such as pareto charts, six sigma/DMAIC, statistics, predictive indicators, process validation, SPC, PFMEA, PPM defective, 8D problem solving, root cause analysis, PPAP, Cpk, etc. The SQE will work both with suppliers and internal stakeholders to ensure intercompany alignment and to deploy all critical to Quality (CTQ) control plans and measurement system analysis. In addition, the SQE will work with cross disciplinary teams to develop the supplier risk management plan and resulting risk mitigation strategy. The SQE will author investigations, problem statements, procedures and other complex forms of communication therefore must possess strong writing skills. This role is a senior level role and will complete responsibilities independently with minimal to no supervision.

What will you be doing?

• Lead the review and execution of supplier provided change notification activities by working directly with suppliers to understand and justify proposed change(s) and working with cross functional teams to assess and approve/reject the change(s). File completed records per procedure.

• Work directly with suppliers to improve product quality and to mitigate, control and resolve supplier quality issues. Work with the Manufacturing Quality Engineering team to improve supplier performance and ensure reliable supply chain. Enlist support from internal company personnel and departments as needed.

• Serve as a lead auditor as well as a supporting auditor for both proposed suppliers and the existing supplier base as required.

• Participate in supplier onboarding and supplier maintenance by reviewing submitted documentation, facilitating and participating in the negotiations for supplier quality contracts and agreements, performing supplier audits as required, and managing the Approved Supplier List.

• Collects NC, supplier corrective actions, deviations and related quality data for trending, scorecard maintenance and supplier performance reports to enable risk mitigation through annual supplier risk plans. Provides key supplier performance metrics to the department manager, senior management and key stakeholders.

• Provides support for the improvement of global and site Supplier Controls procedural requirements, e.g. as supplier qualification, supplier change notification, supplier audit, supplier risk assessments, etc. Initiates and approves engineering change requests if required.

• Supports nonconformances and supplier corrective / preventive action (sCAPA) on supplier related issues by assisting in the root cause analysis and the development of corrective action and proper documentation of objective evidence.

• Provide guidance, leadership, and mentoring for lower-level team members. (remainder).

• Travel Requirements 0-10%.

What will you need to be successful?

• Bachelor's Degree, or higher, in Technical Field (Engineering or Sciences) is required.

• 7+ years of direct quality system experience within a regulated manufacturing industry, or 10+ years quality related experience within a regulated manufacturing industry.

• Problem Solving Skills

• Creative Thinker

• "I Own It" attitude

• Interpersonal Skills

• Decision Making

• Effective Communication

• Self-Motivated

• Personable

• Energetic

• Responsive

• Confident

• Honest and Passionate

• Communication Skills: Verbal/Written

• Knows and adheres to the quality policy of the company and the quality-related procedures and instructions.

• Reports any deviation in product or process, of which he/she becomes aware, to his/her manager or the Quality department.

• Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice).

• Immediately reports any dissatisfaction or complaint which is brought to their attention from a customer or patient regarding a Smith & Nephew product (e.g. in terms of quality, durability, reliability, safety or performance) to the complaints department.

• Complies with all health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities, including medical evaluations as required by job function. Completes all required HSE training.

• Physical Demands: Weightlifting: Light (0kg - 5kg). Position: 50/50 sitting / standing. Repetitive Motion: Low: <10 moves/30sec. Chemical Exposure: No chemicals exposure or cleaning use only. Physical Risk (Personal Protective Equipment - PPE) may be required.

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 Options, 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.