Senior Post Market Surveillance Specialist

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, Post Market performs investigations for complex or critical complaints. This position is also responsible for Quality Engineering support related to post-market activities including complaint investigations, Health Hazard Evaluations, Risk Management, and Post Market Surveillance.

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.

• Perform failure analysis and root cause investigation on returned products including review of Risk Management files and Device History Records

• Document complaint analysis reports in complaint management system

• Ensure complaint investigations are completed within the required timeframe

• Evaluate historical complaint data to identify trends

• Prepare summary and trend reports for evaluation in Management and other reviews

• Participate in Quality Management Reviews as requested

• Coordinate and host regularly scheduled reviews of post market data

• Update Risk Management documentation with post market data

• Prepare Health Hazard Evaluations to analyze potential field product issues.

• Coordinate recall activities if require

• Provide trend information to Post Market Surveillance process,

• Define process improvements and implement solutions to improve the efficiency of post market activities

• Establish and implement post market related procedures and processes

• Support internal and 3rd party audits with post-market related requests

• Collaborate with other supporting departments in the resolution of quality problems using established problem-solving methodologies determining root cause and driving corrective and preventive actions where required

• Other Quality Engineering duties as assigned

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:

• Bachelor’s Degree in a related scientific discipline or appropriate combination of education and experience.

Experience, Skills, Knowledge and/or Abilities:

• Minimum 7 years’ experience in the Medical Device Industry working in a Quality functions

• Demonstrated organizational and communication skills

• Strong attention to detail is required

• Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), and other National and International regulations and standards

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:

• Bachelor’s degree in engineering preferred

• ASQ Certification desire

Additional Experience, Skills, Knowledge and/or Abilities:

• No additional requirements

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 employee who is located in California is $109,111.30 to $ $134,463.66 per year, plus bonus based on performance, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer and this pay scale may not reflect the pay scale for an employee who works in other states or locations.

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.