POSITION DESCRIPTION
JOB TITLE:
Quality Engineer I, II or III (DOE)
DATE:
9/25/14
FLSA:
EXEMPT
APPLICABLE EXEMPTION(S):
NON EXEMPT Professional
SOFTWARE, EXEMPT
DIVISION/DEPARTMENT:
Quality Systems
REPORTS TO:
Director, Quality Systems
LOCATION:
Olympus Respiratory America d/b/a Spiration, Inc. in Redmond, WA
PURPOSE/SUMMARY
The Quality Engineers support the development and manufacture of Spiration products during all phases of
design, development, production, and distribution. All Quality Engineers, in one manner or another, are
responsible for:
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Acting as the Quality Representative on the Product Development project teams
Supplier management, including supplier qualification, audits, and annual reviews
Inspection and test methods and systems
Complaint handling and product investigations of device returns
Corrective and preventive action
Maintenance of Spiration quality management system by ensuring compliance to U.S. and international
regulatory requirements for medical devices
Internal quality audits.
PRIMARY DUTIES AND RESPONSIBILITIES
1.
Support design and development projects
a. Represent the Quality team. Provide input and coordinate activities related to:
 Risk analysis activities (design and process FMEAs)
 Supplier sourcing, qualification, and selection
 Acceptance criteria and inspection methods of components and assemblies
 Product labeling and specifications
b. Develop and maintain Design History File
c. Provide project team with guidance on compliance to Product Development Process
d. Assist in regulatory submissions, as required.
2.
Supplier Management
a.
Supplier Management Team (SMT) member supporting the evaluation, risk analysis,
qualification, approval and monitoring of Spiration suppliers
b.
Perform supplier audits, as required
c.
Conduct annual reviews of approved suppliers
d.
Issue and track Supplier Corrective Action Requests to closure
e.
Maintain Approved Supplier List.
3.
Support and maintain device production and distribution activities
a.
Facilitate and continually improve complaint handling system. Perform and coordinate
investigations of product returns in a timely manner.
b.
Review and approve release of or changes to specifications and drawings, evaluating design
change impact, including effect on inspection, verification/validation, risk analysis,
sterilization, and biocompatibility
c.
Identify areas requiring corrective and preventive action, including those resulting from nonconforming product. Coordinate activities associated with planning and implementing
solutions. Follow up, as required, to ensure effective implementation
d.
Provide data collection, review, and analysis of processes supporting production and product
quality. Communicate information effectively
e.
Quality representative for Material Review Board (MRB) activities.
2.
Corrective and Preventive Action
a.
Assist in maintenance of CAPA Log or database and coordination of CAPA Review Board
meetings
b.
Complete assigned CAPA actions
c.
Conduct and document verification of implementation and effectiveness of corrective
and/or preventive actions
2.
Support and participate in inspection and test activities.
a.
Review and approve inspection requirements
b.
Assist in inspection processes through development of inspection tools and aides; i.e., go/no
go gages, visual standards, and reference samples
c.
Review and approve first article inspections
d.
Determine compliance to specifications.
3.
Support Spiration quality management system
a.
Perform or assist in hosting internal audits according to approved schedule.
b.
Maintain SPC database and expand implementation, as needed.
c.
Create/revise SOPs and work instructions.
4.
Sterilization and Biocompatibility
a.
Assist in coordinating the development of sterilization processes, validation, revalidation,
and routine monitoring.
b.
Review sterilization test results for final product release. This includes, but is not limited to,
EO residuals, sterility, and bacterial endotoxins (pyrogen).
c.
Assist in determining applicable biocompatibility requirements for US and international
compliance. Coordinate biocompatibility testing with outside laboratories.
5. Trend analysis and data reporting for identified performance measures.
MINIMUM QUALIFICATIONS (To perform this job successfully, an individual must be able to perform each
essential duty satisfactorily. The requirements listed below are representative of the, education, knowledge,
skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities
to perform the essential functions.)
EDUCATION
 BS degree in a technical discipline is required. Evidence of continued learning efforts a plus.
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EXPERIENCE
 2++ years in a medical device manufacturing environment. Previous Quality Engineering experience
preferred.
CERTIFICATIONS/LICENSES
 ASQC CQA and/or CQE preferred.
SKILLS, ABILITIES, KNOWLEDGE
 Knowledge of ISO 13485, 21 CFR Part 820, 93/42/EEC Medical Devices Directive, SOR 98/282, Canadian
Medical Device Regulations, 21 CFR Part 11, ISO 14971, ISO 11135, ISO 10993-1, ISO 11607 and other
medical device industry US and international standards.
 Experience with risk analysis and reliability engineering techniques.
 Identifying requirements, setting realistic scheduling and meeting deadlines.
 Ability to identify issues, determine root cause, and implement solutions.
 Ensure compliance to standards, regulations and Company procedures.
 Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of
continuous improvement.
 Advanced Microsoft software skills including sophisticated Word, Excel and Powerpoint skills a must.
Access, Visio, database and statistical analysis software experience optimal.
 Sophisticated written and verbal communication skills, including previous experience in
procedure, protocol and report writing required.
 Must be highly and effectively organized as well as a flexible self-starter, team-oriented, and excellent at
prioritization and multitasking.
 A natural at fostering collaborative relationships across all lines of the Company.
PHYSICAL DEMANDS
Frequently Lift/Carry up to 25 lbs
Microscope/Fine close work 8 hrs a
day
Vision requirements correctable to
20/20 vision
WORK ENVIRONMENT
Chemicals/Solvents
Infectious Disease exposure
Radiation
Frequently Push/Pull
50+ lbs
Bend/Stoop/Kneel 2 hrs a day
Stand/Sit/Walk 8 hrs a day
Dexterity required
Operate moving vehicles
Other
Clean Room
Laser
ETO exposure
Eye Protection
Noise above 85 decibels
Other
Spiration d/b/a Olympus Respiratory America is an
Equal Opportunity Employer
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