-
Regulatory Affairs Specialist
3 weeks ago
Atec Spine Carlsbad, United StatesATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...
-
Sr. Specialist, Regulatory Affairs
2 weeks ago
Atec Spine Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Sr. Specialist, Regulatory Affairs
2 weeks ago
Atec Spine Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Sr. Specialist, Regulatory Affairs
1 week ago
Atec Spine Carlsbad, United StatesThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions.Essential D ...
-
Sr. Specialist, Regulatory Affairs
2 weeks ago
Atec Spine Carlsbad, United StatesThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions. · Essenti ...
-
Regulatory Affairs Specialist
3 weeks ago
Internetwork Expert Inc Carlsbad, United StatesATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...
-
Regulatory Affairs Specialist
3 weeks ago
Alphatec Spine Carlsbad, United StatesATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...
-
Regulatory Affairs Specialist
2 weeks ago
Internetwork Expert Inc Carlsbad, United StatesATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Alphatec Spine Carlsbad, United StatesThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions. · Essentia ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Alphatec Spine Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Internetwork Expert Inc Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Sr. Specialist, Regulatory Affairs
2 weeks ago
Internetwork Expert Inc Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Regulatory Affairs Specialist
3 weeks ago
Alphatec Spine Carlsbad, United StatesJob Description · Job DescriptionATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clear ...
-
Sr. Specialist, Regulatory Affairs
1 week ago
Alphatec Spine Carlsbad, United StatesJob Description · Job DescriptionThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulator ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Alphatec Spine Carlsbad, United StatesJob Description · Job DescriptionThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product ...
Senior Post Market Surveillance Specialist - Carlsbad, United States - Orthofix Holdings, Inc.
Description
Senior Post Market Surveillance Specialist page is loadedSenior Post Market Surveillance Specialist
Apply
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.
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.
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 the8th 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.
#J-18808-Ljbffr
