Quality Engineer, Sustaining Product Quality
Company: Orchid Orthopedics
Location: Hillsboro
Posted on: July 27, 2022
Job Description:
SUMMARY OF POSITION
The Quality Tech II is responsible for a variety of activities to
ensure quality and compliance needs are met. S/he is responsible
for manufacturing readiness quality planning, sustaining process
quality, continuous improvement initiatives, and compliance
adherence.
SHIFT
No Shift ($0) (United States of America)
WHAT YOU WILL DO
- Uses quality tools to implement improvements including: process
flowcharting, Pareto analysis, correlation and regression analysis,
significance tests, design of experiments, statistical process
control, gauge repeatability and reproducibility, and trend
analysis techniques.
- Acts as a customer liaison and processes customer quality
complaints, as applicable.
- Collects, Analyzes, and Presents data using statistical
methodology
- Assists suppliers with the interpretation of quality
requirements, as applicable.
- Assists the development of essential QMS deliverables/Advanced
Product Quality Planning (APQP) including, but not limited to:
complaint analysis, risk analysis, failure mode and effects
analysis, CAPA, and process/equipment/software verification /
validation
- Plans and/or conducts process and equipment validations and
special validations including installation qualification (IQ),
Operational Qualification (OQ), and Performance Qualification
(PQ).
- Determines machine and/or process capability through planning
and/or executing Process Capability studies
- Develops inspection criteria that connect customer requirements
and manufacturing processes that include identification of key
characteristics, associated sampling plans, and required
gauging.
- Interfaces with appropriate customer contacts to clarify
customer requirements
- Conceives and/or Leads productivity improvements and/or
Continuous improvement projects
- Monitors engineering production processes and products for
adherence to internal and external requirements and practices.
- Participates in pre- and post-production launch reviews
providing quality engineering support
- Performs quality reviews and internal audits; evaluates data
and writes associated reports
- Recommends modifications to existing quality or production
standards, where applicable, to achieve optimum quality within
limits of equipment capability.
- Reviews and approves product/process and document change
requests.
- Reviews drawings to evaluate quality requirements including:
correct application of geometric dimensioning and tolerance, proper
use of process and material specifications, and key characteristics
for inspection plans and gauging techniques.
- Supports measuring and analyzing key metrics to monitor
performance.
- Works with cross-functional teams to solve production and
quality problems.
- Reinforces safety expectations. Ensures safety operating
practices are demonstrated. Reports issues/concerns to
Supervisor.
- Support quality and compliance by adhering to all procedures,
work instructions, and forms per the Quality Management Systems
(QMS).
- Provides and documents training on standard of work
instructions, policies, and procedures in a timely manner to ensure
team members have the required knowledge and skills prior to
performing work independently.
WHAT WE ARE LOOKING FOR
WORK EXPERIENCE
3+ Years of Experience (Required), 3+ Years of Experience in a
Manufacturing Environment, Experience in Medical Device
Manufacturing
EDUCATION
Bachelor of Science (B.S) - Engineering Required, , ,
CERTIFICATIONS
Training - Any
KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
Communication (Basic Knowledge), Computer Knowledge (Working
Experience), Decision Making and Critical Thinking (Basic
Knowledge), Flexibility & Adaptability (Basic Knowledge), GD&T
(Working Experience), ISO 13485 (Working Experience), Manufacturing
Industry (Working Experience), Mathematical Ability (Working
Experience), Problem Solving (Working Experience), Quality
Inspection Metrology Tools (Working Experience)
WHAT WE OFFER
- Opportunity to work in a growing company
- Ability to help people live a longer, more active life
- Comprehensive benefit package
- Ability to work in an organization that values:
- Integrity First: We do the right thing
- Teamwork: We are one Orchid
- Results: Our results matter
PHYSICAL REQUIREMENTS
- Must be able to remain in a stationary position. -
Occasionally
- Must be able to move about the inside of the building. -
Constantly
- Must be able to move equipment around the building. -
Constantly
- Must be able to ascend/descend stairs or ladders. -
Frequently
- Must be able to position oneself and move under/around/over
equipment. - Constantly
- Must be able to handle/adjust/inspect/position various items
and equipment. - Constantly
- Must be able to communicate and exchange information with
others. - Frequently
- Must be able to perform tasks that require repetitive
handling/adjusting/inspecting/positioning of items and equipment. -
Constantly
ADDITIONAL REQUIREMENTS
- Candidates offered employment may be required to submit to a
pre-employment background check and pre-employment drug-screening
based on position requirements
- Candidates must be able to provide proof of eligibility to work
in the United States through eVerify
EOE, including disability/vets
Keywords: Orchid Orthopedics, Hillsboro , Quality Engineer, Sustaining Product Quality, Engineering , Hillsboro, Oregon
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