QUALITY ASSURANCE ENGINEER SR (4528109) Job in Salt Lake City 84119, Utah Us
QUALITY ASSURANCE ENGINEER SR (4528109)
POSITION SUMMARY
Develops, modifies, applies, and maintains quality
standards for products and processes. Provides diverse and
complex statistical information for quality improvement by
determining and applying testing methods and criteria.
Responsible to guide technical evaluations, analysis, and
related data acquisition processes to ensure division
quality objectives are achieved.
*Medical device industry experience is MANDATORY for this role.
ESSENTIAL FUNCTIONS
1. Assesses quality performance (or cost-of-quality) using
statistical and analytical methods. Devises and implements
various complex methods and procedures for inspecting,
testing, and evaluating the precision, reliability, and
accuracy of products, processes, and production equipment.
2. Develops and establishes advanced quality systems and
procedures, inspection plans, quality performance trends,
statistical plans, cost estimates, and technical quality
plans for proposals. Ensures that project and/or process
control documentation is compliant with requirements and/or
contract.
3. Assesses the cost of, and determines the responsibility
for, products or materials that do not meet required
standards and specifications by performing difficult
statistical analyses. May establish statistical confidence
by identifying sample size and acceptable error and
determining levels of confidence.
4. Provides input on quality to product development teams;
recommends producibility improvements by facilitating
process reviews, addressing technical data packages,
manufacturing methods, equipment, tooling and training.
5. Identifies quality performance, trends and corrective
action by coordinating with customers and suppliers.
Ensures compliance to specified quality requirements by
performing in-house and supplier audits and surveys.
Develops and initiates programs to improve supplier
performance.
6. Designs or specifies inspection and testing mechanisms
and equipment, and conducts quality assurance tests.
Develops experiments by applying factorial or other
techniques as appropriate for complex products or
processes.
7. Develops sampling plans and inspections by applying
attribute, variable, and sequential sampling methods.
Devises sampling procedures and designs and develops forms
and instructions for recording, evaluating, and reporting
quality data.
8. Develops statistical process controls by applying and
maintaining applicable control charts. Analyzes data by
completing hypothesis, normal distribution, and process
capability analysis tests.
9. Prepares comprehensive reports by collecting,
interpreting, analyzing, and summarizing data and making
recommendations. Analyzes proposed changes in methods and
materials. Compiles and writes training material and
conducts training sessions on quality control activities.
10. Acts as member of the Material Review Board and
participates in related activities, failure analysis and
corrective action investigations.
11. Refines and enhances products and processes by applying
continuous improvement and key lean
manufacturing/production principles and techniques to
critical areas of production.
12. Represents company by interfacing with customers and
regulatory agencies and assisting with internal and
external audits. May act as main contact in audit.
Develops and coordinates corrective action procedures and
plans.
13. Maintains professional and technical knowledge by
attending educational workshops, reviewing publications,
establishing industry networks, benchmarking state-of-the-
art practices, maintaining American Society for Quality
certification, and/or participating in other professional
associations.
14. Complies with federal, state, and local legal
requirements by studying existing and new legislation,
ensuring adherence to requirements, and advising management
on needed actions.
15. May provide leadership to others in department. Acts
as prime contact on high level projects. Establishes
goals, objectives, and metrics required to complete
projects. Trains and mentors less experienced employees.
16. Shares specialized knowledge with others. Represents
company on high-level projects. Contributes to team effort
by accomplishing related results as needed. Work
assignments may include cross-functional or project team
responsibilities (e.g. continuous improvement).
(10/01/1999)
QUALIFICATIONS
Education and Experience
Bachelors degree (BS) in Engineering or a related technical
discipline. Demonstrated ability to perform the essential
functions of the job typically acquired through six or more
years of related experience. American Society for Quality
certification desired.
Knowledge, Skills and Abilities
Thorough knowledge of state-of-the-art inspection and
quality inspection and quality engineering/assurance
techniques, procedures, instruments, equipment, theories,
principles and concepts and general business operations.
Knowledge of Medical Deviceor similar industry
products and legal and regulatory requirements related to
field. Ability to effectively assess and implement
continuous improvement techniques to quality and
manufacturing functions. Ability to use standard business
applications software and/or specialized data analysis
tools. Ability to work on a variety of problems of diverse
scope and complexity where analysis and evaluation of
various outcomes require tradeoffs and negotiation.
Ability to solve a wide range of difficult problems in
imaginative and practical ways and evaluate alternative
solutions that may require coordination across multiple
teams. Ability to establish goals and objectives to
complete projects. Ability to routinely apply project
management skills and to effectively use project scheduling
computer software programs. Ability to read, analyze, and
interpret technical journals, policies and recommend
changes to procedures. Ability to effectively communicate
and present information to team members, team leaders, and
top management. Ability to respond to significant
inquiries or complaints from customers, regulatory
agencies, or members of the business community. Ability to
define problems, collect data, establish facts, and draw
valid conclusions. Ability to effectively demonstrate team
member competencies and participate in goal-setting,
performance feedback, and self-development activities.
TYPICAL MENTAL AND PHYSICAL DEMANDS
While performing the duties of this job, the employee is
required to sit. The employee frequently is required to
use hands to operate a computer and talk and hear. The
employee is occasionally required to stand and walk.
Specific vision abilities required by this job include
close vision. Also expected of the employee is regular
attendance, the ability to work cooperatively and
professionally with others and members of the public, and
the ability to manage multiple tasks at once. The employee
may be required to travel to vendors or customers including
overnight trips.
(The essential functions have been provided as examples of
types of work performed by employees assigned to this job
classification. The Company reserves the right to modify
the work assignments and/or to make reasonable
accommodations so that qualified employees can perform the
essential functions of the job. The physical and mental
demands described above are representative of those
required to successfully perform the essential functions of
this job.)
Req. Code : 11970
Division/Department : SPG - EPS - SLC
% of Travel Required : 0-10%
Skills : Quality Assurance / Lean - QA DeployManager
Other Skills : Equal opportunity/Affirmative action employer. U.S. Citizenship or U.S. Permanent Resident status required.