- Assist in the smooth transition from product design to production by reviewing manufacturing and quality processes for enhancement and risk mitigation.
- Help with after-market monitoring activities, including analysis of servicing data, processing customer complaints, and reporting medical events.
- Participate in implementing corrective and preventive actions (CAPA) for both internal and external findings.
- Collaborate with suppliers on quality enhancement projects through corrective actions.
- Occasional domestic and international travel may be required (~5%).
- Introduce and oversee lean manufacturing initiatives like 5S, line optimization, FMEA, etc.
- Engage in internal and external audits for domestic and international suppliers, potentially involving new supplier approval.
- Drive the efficient transition from product design to production.
- Lead after-market monitoring activities, such as servicing data analysis, customer complaint processing, and medical event reporting.
- Conduct thorough root cause analysis of non-conforming products, implement proper containment measures, and drive corrective actions.
- Support Strategic Sourcing and Purchasing as a Supplier Quality asset.
- Coordinate with supply chain teams to promote collaboration and communication for issue resolution with suppliers.
- Identify and lead the implementation of process, procedure, and system improvements.
- Monitor and analyze production performance trends for key quality metrics and establish suitable control measures.
- Occasional domestic and international travel might be necessary (~15%).
- Evaluate and execute enhanced quality inspection requirements, methods, and testing for early defect detection in production stages and to enhance reliability and repeatability of quality control.
- Engage in the new product design and development process, including risk analysis, protocol establishment, and report preparation for design validation.
- Lead the effective transition from product design to production by reviewing manufacturing and quality processes for improvement and risk mitigation.
- Identify and lead the implementation of process, procedure, and system improvements.
- Lead internal and external audits for domestic and international suppliers, potentially involving new supplier approval.
- Conduct thorough root cause analysis of non-conforming products, implement proper containment measures, and drive corrective actions.
- Must possess a strong work ethic.
- Excellent oral and written communication skills are essential.
- Ability to interact effectively with various departments within the company.
- Proficient in conflict resolution.
- Utilize analytical and problem-solving skills to manage complex project deliverables.
- Solutions-oriented problem solver.
- Attention to detail with precise and comprehensive documentation.
- Excellent planning, communication, and organizational skills.
- Knowledge and willingness to implement lean product development principles.
- Support internal and external audit activities.
- Required knowledge of good documentation practice and laboratory procedures.
- Adhere to all company policies and procedures.
- Assist with any other assigned duties.
- Bachelor's degree in Engineering or related Scientific field, mandatory.
- 0-3 years' experience in manufacturing quality, design control systems, UL and/or CSA compliance testing preferred.
- Preference for medical manufacturing experience.
- Basic knowledge/proficiency of ISO 13485 required.
- Essential knowledge of FDA GMP and quality systems.
- A combination of training, education, and experience equivalent to the qualifications above.
- Bachelor's degree in Engineering or related Scientific field, mandatory.
- 3-5 years' experience in manufacturing quality, design control systems, UL and/or CSA compliance testing preferred.
- Minimum of 2 years of experience in medical device or regulated industry.
- Intermediate knowledge/proficiency of ISO 13485 required.
- Essential knowledge of FDA GMP and quality systems.
- Certifications in Quality Engineering, Auditing, and/or Green Belt are a plus.
- A combination of training, education, and experience equivalent to the qualifications above.
- Bachelor's degree in Engineering or related Scientific field, mandatory.
- Master's degree in Engineering or related Scientific field, preferred.
- 5-7 years' experience in medical device or regulated industry, required.
- Must have 3+ years' experience in manufacturing quality, design control systems, UL and/or CSA compliance testing.
- Preferably a Certified Lead Auditor and Six Sigma Black Belt.
- Advanced knowledge/proficiency of ISO 13485 required.
- Essential knowledge of FDA, GMP, and ISO regulated quality systems.
- A combination of training, education, and experience equivalent to the qualifications above.
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Quality Engineer III - Plano, United States - Inogen
Description
Description of Job Listing
Job Summary
Inogen, Inc. is a prominent global medical technology company that offers innovative respiratory products for homecare use. Inogen plays a vital role in patient respiratory care by creating, producing, and promoting cutting-edge portable oxygen concentrators to provide long-term oxygen therapy to individuals with chronic respiratory conditions.
As a part of Inogen's team, the Quality Engineer (QE) plays a crucial role in supporting various aspects such as manufacturing, supplier quality, new product development transfers, and post-market activities from a quality and regulatory standpoint.
Responsibilities (Specific tasks, duties, essential functions of the job)
Quality Engineer I
Quality Engineer II
In addition to the tasks for Quality Engineer I, Quality Engineer II might also be responsible for the following:
Quality Engineer III
In addition to the responsibilities of Quality Engineer II, Quality Engineer III could also be accountable for the following:
Knowledge, Skills, and Abilities
Qualifications (Experience and Education)
Level I
Quality Engineer I
Level II
Quality Engineer II
Level III
Quality Engineer III
Disclaimer
The statements above aim to outline the general nature of work performed by individuals in this role. They do not intend to be an exhaustive list of all responsibilities, duties, and skills required.
Quality Engineer III professionals in Plano
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Michael Oniya
Sr. Project/Program/Product/Operations Manager