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 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.

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?

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

• 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?

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:

• 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?

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

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

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.