Supplier Quality Engineer

2 Days Old

Why Orthofix?
Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further. How you'll make a difference? The Supplier Quality Engineer (SQE) will be responsible for providing Quality Engineering support for day-to-day operations of Supplier Management and activities relating to supplier selection, evaluation, and performance. The SQE will also be involved in continuous improvement programs and other projects as required. This position requires duties to be performed on-site and frequent travel to conduct supplier audits. Other duties are maintaining the ASL, evaluating new supplier requests, facilitating supplier corrective actions, and working with cross-functional teams to resolve supplier related quality issues. What will your duties and responsibilities be? Develop and continuously improve Supplier Quality for existing, line extension and new products.
Perform Supplier Quality Audits.
Drive resolution of Supplier Corrective Action Requests (SCARS) to ensure effective problem resolution.
Lead the development and execution of Supplier Quality Improvement initiatives (Supplier owned quality, etc.).
Track, trend, and report supplier quality metrics.
Analyze, investigate and follow up on Nonconforming Material Reports (NCMR).
Maintain the Approved Supplier List (ASL) through review and approval of new supplier requests, change requests, and supplier selection plans.
Participate in cost reduction activities.
Ensure continuous improvement and optimization of Supplier management procedures and processes.
Ensure alignment of supplier controls with Receiving inspection
May assist in Supplier related process validation and part qualification activities
Perform Internal audits.
Support site during external audits ( Notified Body, FDA).
What skills and experience will you need? Education/Certifications : Engineering degree or equivalent.
Experience, Skills, Knowledge and/or Abilities : 3+ years’ experience working as a Supplier Quality Engineer in a regulated industry.
Excellent communication skills both written and oral.
Excellent analytical skills.
Ability to organize time and tasks efficiently.
Ability to operate effectively in a team environment.
Travel up to 40%, therefore must be able to travel by airplane, train, taxi and car.
What qualifications are preferred? Education/Certifications : Advanced degree
Additional Experience, Skills, Knowledge and/or Abilities : Experience in Medical device industry is a plus
Knowledge of Oracle, Business Objects and Excel a plus.
Certification in ASQ CQA, CQE, etc.
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS No additional physical requirements or essential functions for this position.
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Location:
Lewisville

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