Senior Quality Engineer

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 position is responsible for performing Quality Engineering activities related to product development and existing product support. The Sr QA Engineer SI approves Quality System documentation, participates in cross functional development teams to develop and release new products, participates / leads cross functional improvement projects and CAPAs, and provides technical support to the QC department.

What will your duties and responsibilities be?

Lead cross functional project teams as needed to accomplish quality objectives.

Review and approve Quality System documentation in compliance with SeaSpine’s procedures, cGMP requirements and statutory requirements (US FDA, ISO, MDD and MDR) including. protocols, technical reports, validation / quality plans, standard operating procedures, risk analysis, design control documents, drawings and specifications

Facilitate the launching of new products, and the transfer of technology from development to commercialization from a Quality perspective :

Develop Design History File deliverables to support timely product launches while ensuring compliance with Quality System and Design Controls principles.

Lead Risk Management activities and ensures that appropriate Risk Management tools (AFMEA / DFMEA / PFMEA) are utilized and consistent with applicable regulatory standards.

Review outputs of Risk Analyses and lead cross-functional efforts to identify appropriate risk mitigation activities.

Support sustaining activities, Quality Control and Calibration department :

Develop and maintain inspection plans using appropriate methodologies to ensure products meet specification and are safe / effective for use

Facilitate MRB activities as assigned by QA management

Support Calibration and Preventive Maintenance activities.

Conduct Out of Tolerance investigations.

Develop statistically based sampling plans for in-process and final testing and inspections, and validations.

Interface with contract manufacturers to develop inspection techniques and support non-conformance investigations

Use quality engineering tools for problem solving ( DMAIC, SPC, DOE).

Identify and implement opportunities for continuous improvement. Interact and coordinate activities with other departments, external vendors and customers. Assist or lead in the prompt implementation of Quality related projects including :

Non-Conformance resolution, Complaint Investigation and Corrective & Preventative Action(s) (CAPA), Process Validations

Development and implementation of new and updated Quality System procedures for ISO / QSR compliance.

Create / support special in-house and supplier validations (cleaning, water system, sterilization, software validations...).

Lead or support equipment and process validation activities using IQ, OQ, PQ methodology.

Prepare information for Quality Management Reviews and Operational Reviews such as : Trend charts, Pareto Analysis, etc., as required

Participate in FDA inspections, ISO Certification and Surveillance audits and customer audits.

What skills and experience will you need?

Education / Certifications :

Bachelor’s Degree in Engineering, Science, or related field

Experience, Skills, Knowledge and / or Abilities :

Minimum 5 years’ experience

Understanding of medical device Quality System requirements including 21CFR820, ISO13485, and ISO14971

Strong technical skills with ability to provide solutions to a variety of technical problems of moderate scope and complexity

Demonstrated experience and understanding in use of statistical tools

Able to independently manage projects and lead cross functional teams

Strong writing and verbal communication skills and ability to multi-task in fast paced environment

What qualifications are preferred?

Education / Certifications :

ASQ Certifications Preferred

Additional Experience, Skills, Knowledge and / or Abilities :

Minimum 1 year working in the medical device industry is preferred.

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

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 $112,000 to $142,000 per year, plus bonus, and benefits.

DISCLAIMER