Quality Engineer II

Description

Job Summary:

Inogen, Inc. is a leading global medical technology company offering innovative respiratory products for use in the homecare setting. Inogen supports patient respiratory care by developing, manufacturing, and marketing innovative best-in-class portable oxygen concentrators used to deliver supplemental long-term oxygen therapy to patients suffering from chronic respiratory conditions.

As an Inogen team member, the Quality Engineer (QE) is responsible for supporting Inogen manufacturing, supplier quality, new product development transfers and post-market activities from a quality and regulatory perspective.

Responsibilities (Specific tasks, duties, essential functions of the job)

Quality Engineer I

• Assist in the effective transition from product design to production. Review manufacturing and quality processes for improvement and risk.
• Assist in after-market monitoring activities, such as analysis of servicing data, customer complaint processing and medical event reporting.
• Participate in implementation of appropriate corrective action and preventative action (CAPA) for internal and external findings.
• Work with suppliers on quality improvement projects through use of corrective actions.
• Occasional domestic and international travel required (~5%).
• Introduction and monitoring of lean manufacturing initiatives (5S, line optimization, FMEA, etc)
• Participate in internal and external audits for domestic and international suppliers which may include new supplier approval.

Quality Engineer II

In addition to items listed for Quality Engineer I, the Quality Engineer IImay also be responsible for the following.

• Drive effective transition from product design to production.
• Lead the after-market monitoring activities, such as analysis of servicing data, customer complaint processing and medical event reporting.

• Perform robust root cause analysis of non-conforming products, implementation of appropriate containment, and drive corrective actions.
• Work with Strategic Sourcing and Purchasing as a Supplier Quality resource.
• Coordinate with supply chain teams to drive collaboration and communication for issue resolution with suppliers.
• Identify and lead implementation of process / procedure / system improvements. For example, component qualification process, skip lot process, supplier change process, etc.
• Monitor / analyze production performance trends for key quality metrics and establish appropriate control measures.
• Occasional domestic and international travel required (~15%).

Quality Engineer III

In addition to items listed for Quality Engineer II, the Quality Engineer IIImay also be responsible for the following.

• Evaluate and implement improved quality inspection requirements, methods and testing to efficiently detect defects in early production stages and to improve reliability and repeatability of incoming, in-process, and final QC.

• Participate in new product design and development process. Measure risk analysis as required. Establish protocols and prepare reports for design validation. Maintain Design History File.
• Lead effective transition from product design to production. Review manufacturing and quality processes for improvement and risk.

• Identify and lead implementation of process / procedure / system improvements. For example, component qualification process, skip lot process, supplier change process, etc.

• Lead internal and external audits for domestic and international suppliers which may include new supplier approval.

• Lead robust root cause analysis of non-conforming products, implementation of appropriate containment, and drive corrective actions.

Knowledge, Skills, and Abilities

• Must have strong work ethic.
• Excellent oral and written communication skills required.
• Ability to effectively interface with different departments within the company.
• Effective conflict resolution.
• Utilize analytical & problem-solving skills to manage complex project deliverables.
• Solutions-oriented problem solver.
• Attention to detail with accurate and complete documentation.
• Excellent planning, communication, and organizational skills.
• Must have knowledge and desire to implement and utilize lean product development principles.
• Must be able to support internal and external audit activities
• Required knowledge of good documentation practice and laboratory procedures.
• Comply with all company policies and procedures.

• Assist with any other duties as assigned.

Qualifications (Experience and Education)

Level I

Quality Engineer I

• Bachelor’s in Engineering or related Scientific field of study, required.
• 0-3 years’ experience in manufacturing quality, design control systems and requirements, or UL and/or CSA compliance testing, preferred.
• Medical manufacturing experience, preferred.
• Basic knowledge/proficiency of ISO 13485, required.
• Basic knowledge in FDA GMP and quality systems, required
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Level II

Quality Engineer II

• Bachelor’s in Engineering or related Scientific field of study, required.
• 3-5 years’ experience in manufacturing quality, design control systems and requirements, UL and/or CSA compliance testing, preferred.
• 2+ years of medical device or regulated industry experience, preferred.
• Intermediate knowledge/proficiency of ISO 13485, required.
• Intermediate knowledge in FDA GMP and quality systems, required
• Certifications in Quality Engineering, Auditing, and/or Green Belt preferred
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Level III

Quality Engineer III

• Bachelor’s in Engineering or related Scientific field of study, required.
• Master’s in Engineering or related Scientific field of study, preferred.
• 5-7 years’ experience in medical device or regulated industry, required.
• 3+ years’ experience in manufacturing quality, design control systems and requirements, UL and/or CSA compliance testing, preferred.
• Certified Lead Auditor, preferred.
• Six Sigma Black Belt, preferred.
• Advanced knowledge/proficiency of ISO 13485, required.
• Advanced knowledge in FDA, GMP, and ISO regulated quality systems, required

• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

The Quality Engineer is responsible for supporting Inogen product development, manufacturing, supplier quality and after-market activities from a quality and regulatory perspective.

Responsibilities (Specific tasks, duties, essential functions of the job)

• Under the guidance of the Quality Manager, participate in new product design and development process. Measure risk analysis as required. Establish protocols and prepare reports for design validation. Maintain Design History File.
• Assist in the effective transition from product design to production. Review manufacturing and quality processes for improvement and risk. Establish Device Master Record.
• Perform after-market monitoring activities, such as analysis of servicing data, customer complaint processing and medical event reporting.
• Perform internal and external audits for domestic and international suppliers which may include new supplier approval.
• Ensure implementation of appropriate corrective action and preventative action (CAPA) for internal and external findings.
• Work with suppliers on quality improvement projects through use of corrective actions.
• Occasional domestic and international travel required (~25%).
• Introduction and monitoring of lean manufacturing initiatives (5S, line optimization, FMEA, etc)
• Participate in new product design and development process. Measure risk analysis as required. Establish protocols and prepare reports for design validation. Maintain Design History File.
• Drive effective transition from product design to production. Review manufacturing and quality processes for improvement and risk. Establish Device Master Record.
• Lead the after-market monitoring activities, such as analysis of servicing data, customer complaint processing and medical event reporting.
• Maintain regular and punctual attendance.
• Comply with all company policies and procedures.
• Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

• Experience with vendor assessment, qualification and process validation.
• Ablity to compile data from various sources to produce useful reports.
• Ability to trend and verify process improvements.
• Must have strong work ethic.
• Excellent oral and written communication skills required.
• Attention to detail is required.
• Effective conflict resolution.
• Analytical & problem-solving skills & ability to multi task.
• Solutions-oriented problem solver.
• Excellent planning, communication and organizational skills.
• Ability to effectively interface with different departments within the company.

Qualifications (Experience and Education)

• Bachelor’s degree in Engineering or related field of study, required.
• 3-5 years’ experience in production, engineering or quality assurance, required. Preferably in a regulated manufacturing environment (i.e. ISO, FDA, FAA).
• Six Sigma black belt, preferred.
• 3 years’ auditing experience, required.
• Advanced knowledge/proficiency in Microsoft Office, and Oracle, required.
• Geometric dimensioning & tolerance (GD&T) training, preferred.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.