Quality Engineer - Operations
Company: Orthofix Holdings, Inc.
Posted on: May 28, 2023
Quality Engineer - Operations page is loaded Quality Engineer -
Operations Apply locations Sunnyvale time type Full time posted on
Posted 2 Days Ago job requisition id OFX23125 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? Summary statement on overall purpose and
function of the position.The position is responsible for performing
Quality Engineering activities related to Operations and Quality
Control of existing product support, and product transfer support.
The Quality Engineer approves Quality System documentation,
participates in cross functional development teams to develop and
release new products, participates/lead cross functional
improvement projects and CAPAs, and provides technical support to
the QC department. 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.
- -Lead cross functional project teams as needed to accomplish
quality objectives. -
- Review and approve Quality System documentation in compliance
with company procedures, cGMP requirements and statutory
requirements (US FDA, ISO, MDD and MDR) including protocols,
technical reports, validation/quality plans, standard operating
procedures, risk analysis, design control documents, drawings and
- Facilitate the launching of new or improved products, and the
transfer of technology from development to commercialization from a
- Develop Design History File deliverables to support timely
product launches while ensuring compliance with Quality System and
Design Controls principles.
- Supports/leads Risk Management activities and ensures that
appropriate Risk Management tools (AFMEA/DFMEA/PFMEA) are utilized
and consistent with applicable regulatory standards.
- Review outputs of Risk Analyses and lead cross-functional
efforts to identify appropriate risk mitigation activities.
- Support sustaining activities, Quality Control and Calibration
- Develops and maintain inspection plans using appropriate
methodologies to ensure products meet specification and are
safe/effective for use.
- Facilitate MRB activities as assigned by QA management.
- Support Calibration and Preventive Maintenance activities.
- Conduct out-of-tolerance investigations. -
- Develop statistically based sampling plans for in-process and
final testing and inspections, and validations.
- Interface with contract manufacturers to develop inspection
techniques and support non-conformance investigations.
- Use quality engineering tools for problem solving (e.g., DMAIC,
SPC, DOE). -
- Identify and implement opportunities for continuous
improvement. Interact and coordinate activities with other
departments, external vendors and customers. Assist or lead in the
prompt implementation of Quality related projects including:
- Non-Conformance resolution, Complaint Investigation and
Corrective & Preventative Action(s) (CAPA), Process
- Development and implementation of new and updated Quality
System procedures for ISO/QSR compliance.
- Create/support special in-house and supplier validations
(cleaning, test method, process equipment, sterilization, software
- Lead or support equipment and process validation activities
using IQ, OQ, PQ methodology.
- Prepare information for Quality Management Reviews and
Operational Reviews such as: Trend charts, Pareto Analysis, etc.,
- Participate in FDA inspections, ISO Certification and
Surveillance audits and customer audits.
- All other 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 Engineering, Science, or a related
field.Experience, Skills, Knowledge and/or Abilities:
- Minimum of 3 years' experience in the medical device industry
- Understanding of medical device Design Control and Quality
System requirements including 21CFR820, ISO13485, and ISO14971.
- Strong technical skills with demonstrated ability to provide
solutions to a variety of technical problems of moderate scope and
- Demonstrated experience and understanding in use of statistical
- Able to independently manage projects and lead cross functional
- Strong writing and verbal communication skills and ability to
multi-task in fast paced environment.
- Supplier auditing experience.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 :
- ASQ Certifications preferred.
- Auditor / Lead Auditor Certifications preferred.Additional
Experience, Skills, Knowledge and/or Abilities:
- Class III product experience preferred.
- Familiarity with Minitab, Oracle and/or other ERP systems
preferred . PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONSThe
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 $84,909 to $96,349 per
year (plus bonus 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.DISCLAIMERThe 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 S--o Paulo,
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.
Keywords: Orthofix Holdings, Inc., Sunnyvale , Quality Engineer - Operations, Engineering , Sunnyvale, California
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