Company: NeuroTech X
Posted on: March 13, 2023
Operations and Quality - Irvine, CA - Full time
Job Title: Quality Engineer
FLSA: Salaried Exempt
Department: Operations and Quality
Reports To: Director, Quality Engineering
To apply, e-mail your resume to
To ensure compliance with the Axonics Quality System, ISO
standards, FDA and Health Canada requirements, and City, County,
State, Fire Marshall and Federal safety regulations. Maintenance
and improvement of policies and procedures focused on delivering
product and services that are in compliance with company Quality
Systems and regulatory requirements.
General Description and Duties:
To perform this job successfully, an individual must be able to
perform each essential task satisfactorily. The tasks listed below
are representative of the knowledge, skill, and/or ability required
to perform this job effectively.
- Quality Systems:Maintain and improve company quality systems in
compliance with FDA, International Standards (ISO), Canadian, and
other regulatory agencies. This function is responsible for
supporting company quality compliance and to provide control of
processes, materials, and product in compliance with the Axonics
- Management:Responsible for departmental supervision, training,
and ongoing support of staff. Required to effectively communicate
project goals and establish staff responsibilities and project
tasks. Provide technical guidance and training (mentorship) to less
senior staff members to contribute to their ongoing development
within the company.
- Product Development:Is a key member of the product development
team representing the Quality function. Steer and support the
design control aspects of product quality, program management, and
quality planning from product design through
- Process Verification and Validation:Provide input regarding
appropriate statistical methods, test methodologies, test
facilities and equipment. Coordinate testing and manage resulting
documentation. This can include process validation, equipment
installation/operational qualification, test method validation,
- Production:May develop and implement quality inspection
procedures including sampling plans, for production level
components, sub-assemblies and finished goods. May also be
responsible for the development and implementation of inspection
methodologies, fixtures, measurement systems and calibration of
- Auditing:Conduct internal and external (e.g. supplier) GMP and
ISO compliance audits. Reports results and recommendations for
changes as required. Confirms acceptable follow up action on
- Documentation:Create, review, and approve controlled documents
on an electronic document control system (e.g. Quality Manual, work
instructions, quality specifications, engineering specifications,
lot history and device master records, procedures and validation
protocols and reports).
- Training:Coordinates and/or provides training to staff in
GMP/ISO, Quality Systems, and Safety awareness. Provides ongoing
development and maintenance of training materials and
- Compliance:Ensures compliance with company quality policies and
practices by participating in product and material reviews, assist
in "troubleshooting" problems related to the manufacture, test,
validation and documentation. Responsible for MRB, corrective
action, process control, complaints, document control, calibration
& preventive maintenance programs and product/process/equipment
- Regulatory:Facilitate compliance with management strategy and
- Product Release:Review and approve lot history records and
sterile load records to ensure product compliance with
specifications and regulatory requirements. Provide support,
guidance, education and training to personnel, ensure inspections,
tests, and sterilization is performed in accordance with
- After Sales Product Monitoring:Coordinate attention to customer
complaints, corrective actions, Medical Device Reports (MDR'S) and
product recalls. As required research and investigate product
failures and the reasons for such.
- Logs & Recordkeeping:Ensure compliance of quality related logs
and records, including but not limited to CAPA, NCMR, ASL/APSL,
equip0ment CAL/PM, and Training.
- Safety:Develop, implement and maintain required safety programs
for flammable, hazardous and bio-hazardous material handling,
storage and disposal in compliance with City, County, State, Fire
Marshall and Federal safety regulations.
Projects and Other Duties:
- Perform other duties as assigned
- Extensive experience and knowledge of regulatory requirements
such as GMP's, ISO, etc.
- Knowledge of and ability to effectively us analytical tools and
methods including statistics, DOE, and the use of computer software
packages related to testing, data collection, calibration,
- Strong understanding of medical device manufacturing processes,
receiving inspection, in-process and finished device inspections,
non-conforming material resolution, CAPA, and record
- Strong understanding of internal and supplier auditing, process
validation, metrology, and inspection equipment.
- Thorough knowledge of applicable City, County, State, Fire
Marshall and Federal safety regulations.
- Excellent communication skills (both written and verbal)
- Ability to work independently or in team setting
- Must be able to travel extensively (approximately 10-20% of
- MS/BS in Engineering or scientific discipline or equivalent
- Up to 3 years Quality role in Medical Device or related
Aligning our overall business objectives with performance and merit
based pay, Axonics offers competitive salaries, performance-based
incentives, and Employer paid benefits programs to address the
diverse individual needs of our employees and their families. At
Axonics, our employees come first!
For California, the base pay range for this position is $80,000 to
$102,000 (highly experienced).
The pay for the successful candidate will depend on various factors
(e.g., qualifications, education, prior experience).
Axonics is an Equal Opportunity Employer, included protected
Veterans and individuals with disabilities.
Please to learn more.
Keywords: NeuroTech X, Irvine , Quality Engineer, Engineering , Irvine, California
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