Senior Quality Engineer
$115,000 - $125,000 / yr
To ensure compliance with our clients 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 comply with company
Quality Systems and regulatory requirements. The primary area of focus is the electronics manufacturing
support for IPG (implantable Pulse Generator).
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are
representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
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 companies Quality System.
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.
function. Steer and support the design control aspects of product quality, program management, and
quality planning from product design through manufacturing.
methodologies, test facilities and equipment. Coordinate testing and manage resulting documentation.
This can include process validation, equipment installation/operational qualification, test method validation,
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 such.
and recommendations for changes as required. Confirms acceptable follow up action on audits.
system (e.g. Quality Manual, work instructions, quality specifications, engineering specifications, lot history
and device master records, procedures and validation protocols and reports).
awareness. Provides ongoing development and maintenance of training materials and records.
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 validation activities.
compliance with specifications and regulatory requirements. Provide support, guidance, education and
training to personnel, ensure inspections, tests, and sterilization is performed in accordance with
Medical Device Reports (MDRs) and product recalls. As required research and investigate product failures
and the reasons for such.
to CAPA, NCMR, ASL/APSL, equipment CAL/PM, and Training.
and Federal safety regulations.
• Perform other duties as assigned.
use of computer software packages related to testing, data collection, calibration, etc.
finished device inspections, non-conforming material resolution, CAPA, and record keeping.
components and plastic molding.
• Experience with laser welding processes and with failure investigations and/or root cause analysis.
• Experience working with new product development as well as sustaining engineering of commercialized
• Experience with design transfers, equipment validation, process validation.
• Knowledge of NCMRs, CAPAs, device complaint investigations and risk assessments.
• ETO sterilization process experience, clean room controls, micro-biological testing and familiarity with
packaging for ETO processed devices a plus.
• Supplier quality/audit experience a plus.
• Thorough knowledge of applicable City, County, State, Fire Marshall, and Federal safety regulations.
• Excellent communication skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Must be able to travel extensively (approximately 10-20% of time).
• MS/BS in Engineering or scientific discipline or equivalent experience.
• 6+ years Quality role in Medical Device or related industry, high risk electronic devices a plus.
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