JOB TITLE: Director of Quality Assurance
ESSENTIAL DUTIES AND
RESPONSIBILITIES include the following. Other duties may be assigned to
meet business needs.
quality assurance objectives by recruiting, selecting, orienting, training,
assigning, scheduling, coaching, counseling, and disciplining employees;
communicating job expectations; planning, monitoring, appraising, and reviewing
job contributions; planning and reviewing compensation actions; enforcing
policies and procedures.
quality assurance operational objectives by contributing information and
analysis to strategic plans and reviews; preparing and completing action plans;
implementing productivity, quality, and customer-service standards; identifying
and resolving problems; completing audits; determining system improvements;
quality assurance financial objectives by estimating requirements; preparing an
annual budget; scheduling expenditures; analyzing variances; initiating
quality assurance plans by conducting hazard analyses; identifying critical
control points and preventive measures; establishing critical limits, monitoring
procedures, corrective actions, and verification procedures; monitoring
quality processes by establishing specifications and quality attributes;
Documenting evidence; determining operational and performance qualification;
writing and updating quality assurance procedures.
and improves quality by completing compliance and surveillance audits;
investigating customer complaints; collaborating with other members of
management to develop new procedure and process designs and training methods.
quality documentation and reports by collecting, analyzing and summarizing
information and trends including failed processes, stability studies, recalls,
corrective actions, and re-validations.
job knowledge by studying trends in and developments in quality management;
participating in educational opportunities; reading professional publications;
maintaining personal networks; participating in professional organizations.
department and organization reputation by accepting ownership for accomplishing
new and different requests; exploring opportunities to add value to job
current return process; build out short, mid and long term improvement plan
business group to implement customer and vendor friendly returns process
return metrics and create root cause improve plan
Supply Chain team to create and implement vendor vetting, correction action and
quality measurement program
customer team to create and implement a customer feedback/survey program
quality RTN %
debit, write off $’s
QUALIFICATION/REQUIREMENTS: Process Improvement,
Analyzing Information , Strategic Planning, Verbal Communication, Informing
Others, Quality Management, Emphasizing Excellence, Attention to Detail,
Thoroughness, Dealing with Complexity
- Strong analytical skills and experience
with implementation and administration of Quality Assurance metrics, such
as defect profiles and performance to entry/exit criteria.
- Excellent problem solving, interpersonal
communication and project management skills a must.
- Strong leadership skills that inspire team
confidence and respect while motivating team members in a creative and
- Must have a desire for achieving excellence
in customer satisfaction, process, quality and reliability.
- Must have experience in managing and
working with distributed team members.
- Knowledge of internet and e-business
processes, disciplines and standards.
- Must be extremely detail-oriented with
respect to documentation and communication.
- Regulatory compliance/ medical device
industry experience a plus.
- BS/BA degree in computer science,
engineering or related discipline.
- Minimum of 7 years of quality assurance
experience, to include a minimum of 3 years in a lead role or management