Supplier Quality Engineer II

Orthofix Holdings, Inc.; Lewisville (TX); On-site; USD 98,000 - 117,000; Full time

Job summary

Orthofix Holdings, Inc. in Lewisville, Texas, is seeking a Supplier Quality Engineer to support supplier management, audits, and corrective actions on-site with frequent travel to supplier sites.

You will lead supplier quality improvements, maintain the Approved Supplier List, and collaborate with cross-functional teams to resolve quality issues. A BS in engineering and 3+ years in a regulated environment are required.

Qualifications

• BS in Engineering or equivalent.
• 3+ years’ experience as a Supplier Quality Engineer in a regulated industry.
• Excellent communication and analytical skills.
• Ability to travel up to 40%.

Responsibilities

• Develop and improve supplier quality for existing, line extension and new products.
• Perform Supplier Quality Audits.
• Drive resolution of Supplier Corrective Action Requests (SCARS).
• Lead development and execution of Supplier Quality Improvement initiatives.
• Track, trend, and report supplier quality metrics.
• Maintain the Approved Supplier List (ASL).
• Support internal and external audits (FDA, Notified Body).

Skills

Excellent communication

Analytical skills

Team collaboration

Education

BS Engineering

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

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• 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

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

• 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

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

• 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.

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 associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws. This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.

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

Since 1980, Orthofix has evolved and grew to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix‑SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide. Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil. Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality‑driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.