Supplier Quality Engineer II
Orthofix
Summary
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.
Job description
JOB PURPOSE
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.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- 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 (i.e. Notified Body, FDA).
MINIMUM QUALIFICATIONS
Education/Certifications
- B.S. 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.
PREFERRED QUALIFICATIONS
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.
Requirements
- B.S. Engineering degree or equivalent.
- 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.
- Advanced degree (preferred).
- Experience in Medical device industry is a plus.
- Knowledge of Oracle, Business Objects and Excel a plus.
- Certification in ASQ CQA, CQE, etc.
Benefits
- Bonus
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
Company overview
Orthofix is a leading global medical technology company headquartered in Lewisville, Texas, specializing in orthopedic and spine solutions. Founded in 1980, the company has evolved into one of the world's premier medical device companies with a focused expertise in spine and limb reconstruction. Orthofix delivers life-changing solutions to patients worldwide by providing advanced medical technologies that heal musculoskeletal pathologies. The company offers a comprehensive portfolio that includes spinal hardware, bone growth therapies, specialized limb reconstruction solutions, biologics, and enabling technologies such as the innovative 7D FLASH™ navigation system. With operations spanning multiple countries and serving healthcare providers globally, Orthofix maintains a strong commitment to clinical excellence and innovation. The company collaborates with leading clinical organizations including MTF Biologics and Texas Scottish Rite Hospital for Children to develop groundbreaking technologies. As a publicly traded company on NASDAQ under the symbol OFIX, Orthofix reported $799.5 million in net sales for 2024 and continues to expand its market presence through strategic focus on spinal fixation, deformity correction, and bone growth therapies.