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Senior Post Market Surveillance Specialist

4 months ago

Carlsbad, United States Orthofix Holdings, Inc. Full time

Senior Post Market Surveillance Specialist page is loaded

Senior Post Market Surveillance Specialist

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locations

Carlsbad

time type

Full time

posted on

Posted 4 Days Ago

job requisition id

OFX23408

Why Orthofix?

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun 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

$120,000

to

$141,000

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.

About Us

Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.

Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.

Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the

8th Largest Orthopedic Medical Device Company in the World

by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.

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