Supplier Quality Engineer II

orthofix; Carlsbad (CA); On-site; USD 98,000 - 117,000; Full time

Job summary

Orthofix seeks a Supplier Quality Engineer to support day-to-day supplier management and QA activities on-site in California. The role includes supplier audits, SCAR resolution, and cross-functional collaboration to ensure product quality across existing, line extension, and new products.

The incumbent will manage ASL updates, supplier requests, and participate in external audits (FDA/Notified Body). Travel up to 40% is required, with a competitive salary and benefits.

Qualifications

• B.S. Engineering degree or equivalent required.
• 3+ years' experience as a Supplier Quality Engineer in a regulated industry.
• Excellent written and oral communication skills.
• Excellent analytical skills.
• Willingness to travel up to 40% (air/train/car).

Responsibilities

• Develop and improve supplier quality for existing, line extension and new products.
• Perform Supplier Quality Audits.
• Lead the resolution of Supplier Corrective Action Requests (SCARs).
• Track, trend, and report supplier quality metrics.
• Maintain the Approved Supplier List (ASL) through reviews of supplier requests and changes.
• Participate in internal and external audits (FDA, Notified Body).

Skills

Supplier quality experience

Communication skills

Analytical skills

Travel readiness

Education

B.S. Engineering degree

Advanced degree

Tools

Oracle

Business Objects

Excel

Job description

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 unrivaled 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.

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.

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position. No additional physical requirements or essential functions for this position.

The anticipated salary for this position for an employee who is located in California is $ 98,000 to $117,000 per year , plus bonus, and benefits .

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically