142 applicants
Olympus Corporation of the Americas · 3 days ago
Quality Engineer I
Redmond, WA
Full-time
Onsite
Entry Level
$65K/yr - $88K/yr
2+ years exp
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Responsibilities
Support preparation of change orders to part specifications, drawings, and inspection plans.
Support ongoing maintenance of the Quality Management System by revising SOPs, work instructions, and forms.
Coordinate training and assist in development of training materials to promote awareness of Quality and Regulatory requirements.
Support Quality Engineers in hosting and executing Material Review Board (MRB) meetings and activities.
Coordinate and Investigate identified Nonconformances, generate Non-conformance Reports (NCRs), and document investigations.
Complete Corrective Action and Preventive Action (CAPA) tasks as assigned, and support other Quality Engineers in CAPA Coordination.
Facilitate post-market surveillance activities, including complaint investigations and maintaining the complaint handling system.
Meet Key Performance Indicator (KPI) targets for NCRs, CAPAs, Complaints, and other site quality metrics.
Support local Manufacturing Quality team and Design Assurance team in maintaining Design History File (DHF).
Assist in hosting internal and external audits, as well as regulatory submissions as required.
Support and participate in material inspection and test activities, maintain Statistical Process Control (SPC) database, and review sterilization test results.
Assist Quality Engineers with data-gathering activities to support validations and/or studies.
Maintain acceptable standards for attendance, work overtime as needed, and work on-site in Redmond, WA with the option for remote work.
Qualification
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Required
Bachelors’ degree or equivalent in an engineering discipline is required. Biomedical Engineering highly preferred, Bioengineering, Mechanical Engineering, etc. with relevant educational experience for medical device industry also preferred. Evidence of continued learning efforts a plus.
Knowledge of 21 CFR Part 820, 93/42/EEC Medical Devices Directive, SOR 98/282 Canadian Medical Device Regulations, ISO 13485, ISO 14971, and any other medical device industry international standards.
Experience with risk analysis and reliability engineering techniques.
Identifying requirements, setting realistic schedules, and meeting deadlines.
Ability to identify issues determine root cause and implement solutions.
High level of proficiency in Microsoft Word, Outlook, Excel, and PowerPoint required.
This is an on-site position in Redmond, WA with the option to work from home up to two days per week. Normal business hours are 8:00 AM to 5:00 PM. Some travel may be required (less than 5%). Some overtime will also be required.
Preferred
0 – 2 years’ experience operating in any Engineering position, preferably Quality Engineering in a highly regulated manufacturing environment (medical devices, biotech, pharmaceuticals, etc.) is optimal.
Formal education developing problem-solving skills, analytical skills. Specific tools such as process mapping, histograms, FMEA, Cause and Effect Diagrams, etc. preferred.
Visio skills desirable. Experience with statistical analyses such as Minitab software a plus.
High level of verbal and written communication skills. Must demonstrate the ability to generate technical reports and make presentations to management on a regular basis.
Must possess a baseline working knowledge of physics, chemistry, mechanical assembly, equipment calibration, and technical writing.
Benefits
Competitive salaries
Annual bonus
401(k) with company match
Comprehensive Medical, Dental, Vision coverage effective on start date
24/7 Employee Assistance Program
Free virtual live and on-demand wellness classes
Work-life balance supportive culture with hybrid and remote roles
12 Paid Holidays
Educational Assistance
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs including Colleague Affinity Networks
On-Site Child Daycare
Café
Fitness Center
Company
Olympus Corporation of the Americas
At Olympus, we put a lot of good back into the world, and what we do, really matters.
5,001-10,000 employees
H1B Sponsorship
Olympus Corporation of the Americas has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (4)
2022 (3)
2021 (3)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Abigail Hunter-Syed
Director
Lyne Charron-Keller
Executive Director, Global Marketing, Respiratory Business
Recent News
2023-10-25
Company data provided by crunchbase
