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 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! As an Orthofix employee, you will become an integral part
of our culture by continually demonstrating the highest level of
integrity and our beliefs while making an impact to our vision “To
be a highly respected global orthopedic and spine company that
delivers exceptional value to our patients, customers, team
members, partners and shareholders."
Senior Quality Engineer - Complaints How you'll make a
This position is responsible for performing investigations of
complaints, including analyzing returned products, assessing risks,
and escalating issues to meet MDR requirements. The Quality
Engineer – Complaints also performs assessment and filing of
reportable events under USA, European MDD, and other International
medical device reporting regulations. This role will maintain the
processes associated with timely complaints handling, vigilance
reporting and maintaining compliance with established company
procedures as well as the USA Food & Drug Administration (FDA),
European MDD, and worldwide regulations. This position will perform
customer follow-up on product complaints and document the reporting
decisions with respect to MDR, MDD, and other International
requirements. This will involve investigating product complaint
events by coordinating with customers, internal resources, field
employees or international staff as appropriate. The Quality
Engineer – Complaints must be able to accurately document the
investigation details, conduct data analysis and develop reports
for management. Further, the position will be responsible for
maintaining documentation in accordance with regulatory and quality
What will your Duties and Responsibilities be?
Nothing in this job description restricts management’s right to
assign or reassign duties and responsibilities to this job at any
Analyze complaints, including returned product, in a uniform and
timely manner; assist in determining failure mode. Author
investigation detailing macro/microscopic images of the returned
product, identify key details based on surgical reports and
radiographs received, review manufacturing records, and assess
risk. Ensure that complaint files have complete evidence. Be able
to identify missing information, evaluate accuracy of the presented
Review complaint investigations performed by independent
external laboratory for scientific accuracy as well as consistency
and completeness; collaborate with the external laboratory to
complete reports in a timely manner.
Escalate issues to CAPAs if appropriate. Work effectively with
complaint related CAPA Process Owners to determine root cause(s),
formulate and document suitable corrective and preventive actions,
and determine appropriate effectiveness checks.
Work closely with Post Market Surveillance Analyst to monitor,
analyze, and trend complaints. Assist in management of the
complaint process for implants and instruments including
coordinating with, and gathering sufficient data from, customers,
field representatives, internal staff, and outside experts.
Maintain current knowledge of FDA and applicable international
policies and regulations that may affect the company's products and
Perform decontamination of returned products. Dispose of
biohazardous materials and maintain biohazard laboratory.
Assist in other Regulatory, Clinical, and Quality activities in
support of complaint handling actions or as business needs
All other duties as assigned.
What Skills and Experience will you need?
BS in Engineering, Biomedical Engineering, Biology, or other
science or health-related discipline preferred, or an equivalent
combination of education and experience.
Five to seven years of experience within the medical device
industry; hands-on experience with medical device complaint
investigation; spinal or other implant experience (US Class II and
III and EU Class IIa, IIb and III) is preferred.
Strong technical writing, analytical, and critical thinking
Demonstrate strong attention to detail.
Experience working with ISO Quality Systems, GMP guidelines, FDA
regulation, and European MDD.
Ability to handle multiple tasks in a fast-paced,
Proven ability to interact with external representatives,
customers (surgeons, other allied health personnel) and internal
Familiarity with medical device terminology and with
Proactive individual with ability to communicate and work well
with others; excellent written and verbal communication skills.
Working knowledge of Microsoft Word, Excel, PowerPoint, and
Must have the ability to professionally and effectively
communicate concepts, ideas, and knowledge to other individuals and
What will the Physical Demands and Work Conditions be like?
The physical demands described here are representative of those
that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
Regularly required to sit for extended periods of time;
frequently required to stand, walk and use business equipment daily
such as P.C., copier, fax, telephone, etc.; occasionally required
to reach overhead, bend, and lift objects of up to 20 lbs.
Eyesight and hearing must be correctable to standard level.
Orthofix complies with all applicable federal, state, and local
laws regarding equal employment opportunities (EEO) to all
employees and applicants for employment. Orthofix makes its
employment decisions without regard to race, color, religion, sex,
national origin, age, disability, genetic information, or any other
status protected by law. In addition to federal law requirements,
Orthofix complies with applicable state and local laws governing
nondiscrimination in employment in every location in which the
company has employees. This policy applies to all terms and
conditions of employment, including recruiting, hiring, placement,
promotion, termination, layoff, recall, transfer, leaves of
absence, compensation and training.
Posted 30+ Days Ago
About Us HEALING BONES. HEALING LIVES
Orthofix International began in a small farmhouse in Verona
Italy in 1980 when orthopedic researcher Giovanni De Bastiani
recognized the bone’s natural repair capability, a concept he
called “dynamization” and with that in mind, he created the first
external fixation device.
Today, Orthofix has grown to more than 900 employees with
locations in the U.S., Italy, Germany, France, the UK, Brazil,
Australia and Puerto Rico. Our products help patients in 70
countries around the world.
Orthofix is comprised of four strategic business units; Biostim,
Biologics, Extremity Fixation and Spine Fixation. Our products are
widely distributed via the company's sales representatives,
distributors and subsidiaries.
At Orthofix we are committed to clinical research and driven by
new product introductions. We are proud of our strong partnerships
with organizations such as the Texas Scottish Rite Hospital for
Children in Dallas and the Musculoskeletal Transplant Foundation.
We take pride in developing superior products and providing world
class education for surgeons and field-based Orthofix personnel
supporting them around the world.
Orthofix makes a difference in the lives of our patients by
providing our surgeon customers with innovative medical devices to
meet the needs of their patients. Every day we are optimizing our
operations, improving efficiencies and examining our systems to
provide the best support possible to our representatives, surgeons