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Quality Inspector
WA - Redmond
Opportunity Snapshot
This is your opportunity to take a hands-on role in performing mechanical inspections, tests and other quality assurance procedures to support the production demands of our growing company. As the lead inspector, you'll be at the forefront of the emerging, rapidly growing field of minimally invasive pulmonary devices and will enjoy the satisfaction that comes with working towards getting great products out to our customers. If you're a qualified mechanical inspector with experience in first article inspecting, molded/plastic parts and are skilled at using a variety of inspection equipment, this could be the ideal role for you. Quick question for you - click here
The Role
Reporting to the Quality Assurance Supervisor, your primary focus is the hands-on responsibility of performing inspections of materials, parts, processes and products and documenting these results to ensure they meet our standards. Acting as the lead inspector, you'll support the prototype development, early production, and production phases through incoming inspection, First Article Inspection (FAI) and production quality inspection.
In addition to your work involving the inspection stages, you'll also help oversee functions related to records management, non-conforming materials and equipment control. As necessary, you'll perform qualification, verification, and validation testing. It will also be your responsibility to assist in maintaining the equipment calibration system and data entry.
We're looking for someone who is highly skilled in mechanical inspection techniques, so to perform your missions outlined here, you'll need the following skills:
- Geometric dimensioning, tolerancing and calibration basics.
- High competency in reading and interpreting drawing and specifications of machined parts, injection molded components and assemblies.
- Proficiency in mechanical inspection techniques and use of related measurement equipment. Quick question for you - click here
- Experience with machined and injection molded components.
- The ability to perform visual inspection (microscopic and unaided eye) and use video measuring systems.
- Expertise with destructive mechanical testing.
Apart from these technical mechanical skills, you'll also need to be an expert at documentation, as it is a key component of this role. Good (legible) penmanship and writing skills will be an invaluable asset in this role.
We enjoy a collaborative, dedicated culture where our Quality Assurance, Engineering, Manufacturing and Production units work in synch, and you'll be working closely with these groups on problem solving, new projects and various inspection initiatives. 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 lead inspector, you'll continue to enhance and promote our tight-knit culture.
The Requirements
In addition to the qualifications already listed, you'll need:
- At a minimum, a high school diploma or the equivalent combination of relevant on-the-job experience and training.
- 5 to 7 years of experience performing the primary duties of a mechanical inspector and/or quality technician with a focus on mechanical inspection.
- Experience with machined and injection molded components.
- Experience in quality assurance or a related field within a development and manufacturing, medical device or other regulated industry.
- Demonstrated experience using mechanical inspection techniques including measurement, test tools and equipment.
- Proficiency in basic computer programs and data input, including Microsoft Word, Excel, and Outlook.
- Good written and verbal communication skills.
- Basic mathematics and statistical analysis skills
The ability to:
- Work in a clean room environment.
- Work under pressure with multiple priorities .
- Interact internally with a variety of staff.
- Identify areas for improvement and implement solutions.
- Adhere to company policies, procedures and practices.
Preferred but not required:
- Vision systems/coordinate measuring machine (CMM) programming experience.
- Technical trade school certification.
- Course work toward inspection techniques, measurement methods and data analysis.
- American Society for Quality (ASQ) CQI and/certification.
- Relevant college level coursework.
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.
Quick question for you - click here 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
While your mechanical skills and quality and inspection experience is of utmost importance, to excel in this role you should be easy to work with, collaborative and someone who can interface well with different personalities. Since you'll be interacting with employees across all levels of the organization and throughout different departments, stellar communication skills will also be integral to your success in this role.
You'll also need to be comfortable multi-tasking and working in fast paced environment where things change quickly. Priorities shift frequently here, so you should possess the ability to switch gears seamlessly.
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.
Opportunity Snapshot
This is your opportunity to take a hands-on role in performing mechanical inspections, tests and other quality assurance procedures to support the production demands of our growing company. As the lead inspector, you'll be at the forefront of the emerging, rapidly growing field of minimally invasive pulmonary devices and will enjoy the satisfaction that comes with working towards getting great products out to our customers. If you're a qualified mechanical inspector with experience in first article inspecting, molded/plastic parts and are skilled at using a variety of inspection equipment, this could be the ideal role for you. Quick question for you - click here
The Role
Reporting to the Quality Assurance Supervisor, your primary focus is the hands-on responsibility of performing inspections of materials, parts, processes and products and documenting these results to ensure they meet our standards. Acting as the lead inspector, you'll support the prototype development, early production, and production phases through incoming inspection, First Article Inspection (FAI) and production quality inspection.
In addition to your work involving the inspection stages, you'll also help oversee functions related to records management, non-conforming materials and equipment control. As necessary, you'll perform qualification, verification, and validation testing. It will also be your responsibility to assist in maintaining the equipment calibration system and data entry.
We're looking for someone who is highly skilled in mechanical inspection techniques, so to perform your missions outlined here, you'll need the following skills:
- Geometric dimensioning, tolerancing and calibration basics.
- High competency in reading and interpreting drawing and specifications of machined parts, injection molded components and assemblies.
- Proficiency in mechanical inspection techniques and use of related measurement equipment. Quick question for you - click here
- Experience with machined and injection molded components.
- The ability to perform visual inspection (microscopic and unaided eye) and use video measuring systems.
- Expertise with destructive mechanical testing.
Apart from these technical mechanical skills, you'll also need to be an expert at documentation, as it is a key component of this role. Good (legible) penmanship and writing skills will be an invaluable asset in this role.
We enjoy a collaborative, dedicated culture where our Quality Assurance, Engineering, Manufacturing and Production units work in synch, and you'll be working closely with these groups on problem solving, new projects and various inspection initiatives. 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 lead inspector, you'll continue to enhance and promote our tight-knit culture.
The Requirements
In addition to the qualifications already listed, you'll need:
- At a minimum, a high school diploma or the equivalent combination of relevant on-the-job experience and training.
- 5 to 7 years of experience performing the primary duties of a mechanical inspector and/or quality technician with a focus on mechanical inspection.
- Experience with machined and injection molded components.
- Experience in quality assurance or a related field within a development and manufacturing, medical device or other regulated industry.
- Demonstrated experience using mechanical inspection techniques including measurement, test tools and equipment.
- Proficiency in basic computer programs and data input, including Microsoft Word, Excel, and Outlook.
- Good written and verbal communication skills.
- Basic mathematics and statistical analysis skills
The ability to:
- Work in a clean room environment.
- Work under pressure with multiple priorities .
- Interact internally with a variety of staff.
- Identify areas for improvement and implement solutions.
- Adhere to company policies, procedures and practices.
Preferred but not required:
- Vision systems/coordinate measuring machine (CMM) programming experience.
- Technical trade school certification.
- Course work toward inspection techniques, measurement methods and data analysis.
- American Society for Quality (ASQ) CQI and/certification.
- Relevant college level coursework.
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.
Quick question for you - click here 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
While your mechanical skills and quality and inspection experience is of utmost importance, to excel in this role you should be easy to work with, collaborative and someone who can interface well with different personalities. Since you'll be interacting with employees across all levels of the organization and throughout different departments, stellar communication skills will also be integral to your success in this role.
You'll also need to be comfortable multi-tasking and working in fast paced environment where things change quickly. Priorities shift frequently here, so you should possess the ability to switch gears seamlessly.
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.
