Leads the Operations Quality departments, including Quality
Engineering, Quality Inspection, labeling development,
sterilization validation, packaging / shipping validation and
Metrology. Ensures regulatory compliance to applicable domestic and
international requirements. Integrates activities associated with
receiving inspection, in-process inspection, finished product
inspection, and product support quality engineering. Works closely
with Manufacturing, R&D, Regulatory Affairs and other Quality
Assurance areas to support manufacturing process changes, product
design transfers, product sustaining projects and continuous
improvement of Operations Quality. Job duties:
Directs all aspects of the Operations Quality function including
Quality Engineers, Quality Control, Metrology, labeling
development, sterilization validation, and packaging / shipping
validation in compliance with FDA regulations, company SOPs and
other applicable standards.
Prepares annual department budget, staffing requirements and
objectives for Operations Quality. Defines objectives to support
Leads prevention-oriented quality improvement programs in order
to meet company quality goals and objectives.
Leads efforts to establish Operations Quality procedures for all
stages of product realization compliant to FDA regulations, ISO
13485 and applicable standards.
Leads efforts for quality reporting of product-related quality
and performance data and applies statistical methods to proactively
identify product quality issues and trends. Initiates Corrective
and Preventive Actions to ensure product quality and
Reviews and approves procedures designed to ensure successful
testing of critical components, sub-assemblies and assemblies for
conformance to specifications and standards.
Leads teams who provide technical services to R&D and
Sustaining Engineering for equipment/tooling qualification and
Leads training programs designed to develop and increase
employees’ quality skillset, including statistical techniques.
Remains informed about developments and trends in quality
control and makes recommendations for appropriate corrective
Ensures the quality policy/system is planned, understood,
implemented and maintained within the department.
Ensures departmental compliance as well as appropriate
departmental resources are available to effectively maintain the
Performs additional duties as assigned.
Bachelor’s Degree in science or engineering.
Minimum ten (10) years of engineering experience in the medical
Five (5) years of management experience.
Knowledge of US and foreign regulations relative to the design,
manufacturing, distribution and servicing medical devices; quality
system and other standards for the medical device industry.
Excellent written and verbal communications.
Reading and preparing technical documentation.
Good interpersonal skills.
Excellent management skills with ability to assign and monitor