The Role

Reporting to our Director, Quality Systems, you will join a group that also includes a Senior Quality Engineer, Senior Quality Systems Specialist, Quality Assurance Supervisor, Quality Technician and Inspector. Right off the bat you'll contribute to our efforts to scale up cutting edge processes for commercial launch of a FDA Class III medical device.

You'll divide the majority of your time between two key areas: manufacturing support and supplier management. In both areas, we have systems and processes in place, of course, and you will maintain those. At the same time, you'll evaluate our existing systems to identify ways to streamline and improve them as we scale up. In these efforts you'll work closely with Manufacturing Engineering and Operations.

Your specific activities will include:

• Overseeing supplier management, including supplier qualification, audits, and annual reviews.
• Evaluating current inspection systems for efficiency and implementing improvements. Quick question for you - click here
• Performing process validations, including EtO sterilization and quality systems software.
• Performing product investigations of device returns, facilitating corrective and preventive action throughout all areas of the company.
• Participation in maintaining the Spiration quality management system by ensuring compliance to US and international regulatory requirements for medical devices, and performing internal quality audits as required.

We enjoy a collaborative, dedicated culture where our Quality Assurance, Engineering and Manufacturing units work in synch. Our pioneering technologies can be fun and exciting to develop and can fill you with a sense of pride, knowing you are helping to improve someone's quality of life. Yes, we are growing -- we have sixty-some full-time employees -- but we're still small enough that each of us contributes on multiple levels. As a supervisor and inspector, you'll continue to enhance and promote our tight-knit culture.

The Requirements

In addition to the qualifications already listed, you'll need:

• A BS in a technical discipline.
• Experience in supplier audit and qualification.
• Experience establishing and maintaining inspection systems and processes.
• Knowledge of process validation activities and associated regulatory constraints.
• Familiarity with machines, equipment, and electronic devices related to engineering, manufacturing, and quality processes.
Quick question for you - click here
• Familiarity with the operation of basic computer programs and associated systems, including Microsoft Word, Excel, Outlook, PowerPoint and statistical software.
• Excellent interpersonal skills.
• Solid written and verbal communication skills, including experience documenting systems and processes.
• A team player attitude and a willingness to contribute along with everyone else.

Preferred but not required:

• ASQ CQA and/or CQE certification.
• Internal quality auditing experience.
• Working knowledge of US FDA Regulations, Medical Devices Directive, and medical device international standards.
• Experience with ethylene oxide (EtO) sterilization validation.
• Experience in smaller and/or start up companies.
• Experience with electronic databases.

Why Spiration

High potential product:  The IBV Valve System has received CE Mark approval and is being marketed in Europe.  In the U.S. the IBV Valve System received Humanitarian Device Exemption (HDE) market approval for the treatment of prolonged air leaks following specific lung surgeries.  The device is also under investigation in the U.S. as a new treatment for patients with severe emphysema.

Autonomy and support:  While we'll look to you to achieve your goals with minimal supervision, the Quality Assurance group works collaboratively to help one another resolve issues.  You'll have support when you need it and independence when you don't.

Great work environment:  At Spiration, we pride ourselves on our scientific expertise and cutting-edge technologies.  We have created a culture that is open, collaborative, and fun with leadership committed to quality and regulatory compliance.  If you're not already familiar with Redmond, WA, it is a hub of medical device and biotech industries, and a beautiful suburb of Seattle.

A proud subsidiary of the Olympus Corporation:  In 2010, we joined Olympus Medical Systems Corp (OMSC), a world leader in the respiratory market with solutions for endoscopic observation, diagnosis and treatment.  In this partnership, Spiration Inc.-Olympus Respiratory America will continue to expand its business to address acute and chronic conditions of the lung through the development of novel therapies

Excellent compensation:  In addition to a competitive salary, we offer a rich benefits package that includes excellent health care, vacation and other paid leave. 

Keys to Success

To excel in this role, you will hit the ground running and bring not only an enthusiastic commitment to our mission, but also a willingness to do what it takes to get the job done. As the second Quality Engineer at Spiration, and you'll have plenty of opportunities to make a significant impact. In addition, in order to be an outstanding Quality Engineer, you will:

• Be comfortable in a fast paced environment, including effectively managing multiple competing projects and priorities, often in pressure situations.
• Bring a collaborative approach and be easy to work with.
• Effectively contribute to teams, but also work independently while keeping the Director in the loop.

If this sounds like the right mix of challenge and opportunity for you, and you meet the minimum qualifications, we want to hear from you!

About Spiration

Spiration is committed to improving the quality of life for patients with acute and chronic conditions of the lung through the development of novel therapies. Our company was founded in 1999 in Redmond, WA, and in 2010, became part of Olympus Medical Systems Corp. Spiration Inc.-Olympus Respiratory America will continue its mission to be a pioneer in the field of lung therapy.