Orthofix International NV

Supplier Quality Engineer II

Orthofix International NV$98K — $117K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • B.S. in Engineering or equivalent required
  • 3+ years experience as a Supplier Quality Engineer in a regulated industry
  • Excellent verbal and written communication skills
  • Strong analytical skills
  • Efficient time and task organization
  • Team collaboration ability
  • Willingness to travel up to 40% of the time

Responsibilities

  • Develop and enhance Supplier Quality for all products
  • Conduct Supplier Quality Audits
  • Resolve Supplier Corrective Action Requests (SCARS)
  • Lead Supplier Quality Improvement initiatives
  • Monitor and report on supplier quality metrics
  • Investigate and follow up on Nonconforming Material Reports (NCMR)
  • Maintain the Approved Supplier List (ASL)

Benefits

  • Professional development opportunities
  • Flexible work environment
  • Collaborative team culture
  • Potential for travel
  • Contributions to continuous improvement programs
Full 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

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+ yearsexperience 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.

The anticipated salary for this position for an employeewho is located in Californiais98,000to117,000per 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 employee9s at-will employment status.

About Orthofix International NV

Orthofix Medical Inc. is a global medical device company focused on musculoskeletal healing products and value-added services. The company's products are used by orthopedic surgeons, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals to treat patients with musculoskeletal conditions resulting from degenerative diseases, deformities, traumatic events and sports-related injuries. The company's products include implants, biologics, external fixation devices, bone stimulation devices, and other products and services. Orthofix Medical Inc. was founded in 1987 and is headquartered in Lewisville, Texas.
Learn more about Orthofix International NV
Size
1,087 employees
Market Cap
$388.6 million
Industry
Net Income
$23.5 million
Founded
1980
5 Year Trend
+2.5%
Revenue
$410.4 million
NASDAQ

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