Senior Quality Engineer, Operations

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 Senior Quality Engineer – Operations will engage with cross functional members to drive Quality performance and to ensure that product quality meets all internal and external requirements. They will lead initiatives to improve quality and customer satisfaction. This individual will also ensure compliance with Quality system and other standards and regulations, company quality requirements and corporate objectives.

What will your duties and responsibilities be?

Assists with complaint handling investigation as assigned

Initiates Corrective Action Requests (CAPA) based on internal NCMR investigation findings as required by QMS

Tracks, trends, and reports quality metrics. Investigate and disposition non-conformances

Works with suppliers to solve problems until resolution

Works to improve quality, reduce product / process issues, cost, and lead time

Supports continuous improvement initiatives

Develops inspection procedures and test methods

Creates work instructions, procedures, protocols etc. as needed for projects

Approves QMS documentation including validations, preventive maintenance, inspection methods and other deliverables as required by the QMS

Initiates Quality Holds when needed and monitor until closure

Performs Quality Audits as assigned

Supports external audit activities from FDA, Regulatory agencies etc.

What skills and experience will you need?

Education / Certifications :

Engineering degree or equivalent

Experience, Skills, Knowledge, and / or Abilities :

6-10 years of experience working in a regulated manufacturing environment

Excellent communication skills both written and oral

Excellent analytical skills

Travel required up to 10%, therefore must be able to utilize airplane, taxi and car

What qualifications are preferred?

Education / Certifications :

N / A

Additional Experience, Skills, Knowledge, and / or Abilities :

Knowledge of Oracle, Business Objects and Excel

Experience working in Medical Device Industry

ASQ Certification

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

No additional physical requirements or essential functions for this position

DISCLAIMER