Quality Control Coordinator Lead at Inogen Inc in Richardson, Texas

Job Description:

QUALITY CONTROL COORDINATOR LEAD

Richardson, TX, USA Req #163
Wednesday, October 28, 2020

ABOUT INOGEN Inogen was founded in 2001 to improve quality of life and increase freedom and independence for oxygen therapy users. Inogen is innovation in oxygen therapy. The Inogen mission is to improve freedom and independence for oxygen therapy patients through innovative products and services. Inogen is a manufacturer and Accredited Homecare Provider.

Inogen is focused on quality care, continuous improvement, and outstanding customer satisfaction. We are a stable, USA based company dedicated to providing an exciting and rewarding career to our employees. We completed a successful Initial Public Offering on the NASDAQ in 2014 and have demonstrated substantial growth over the last five years. Our work environment is casual yet high performing, and we are looking for seriously talented, motivated, and fast-paced professionals to join our team.

Job Summary:

The Quality Control Coordinator will be responsible for a variety of activities to support production from a quality and regulatory perspective.This includes but is not limited to performing inspections; ensuring accurate production floor documentation; validation of material receipt and returns; and supporting overall quality improvements in production.

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

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Perform incoming inspection of received materials and components.
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Conduct Material Review Board (MRB) for parts rejected at incoming inspection, production and field returns.
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Perform Device History Record (DHR) review and product release.
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Ensure production floor documentation is accurate and complete.
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Create debit memos for Return to Vendor (RTV) of non-conforming material.
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Assist Accounts Payable with RTV credits that do not coincide with vendors.
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Perform audits and inspection of work instructions and of standard operating procedures.
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Ensure strict compliance to cGMP, current Good Manufacturing Practices.
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Inspect goods to ensure customer expectations are met.
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Review Bill of Materials (BOM s) prior to the beginning of a production run.
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Conduct line clearance audits prior to production operations.
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Record, correct and re-test out of specification results.
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Participate in manufacturing process validations as needed.
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Ensure cleanliness of production areas and report any unacceptable details to Shift Supervisor.
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Perform quality audits and product audits as specified to verify product
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Perform evaluations and qualifications of production and quality assurance equipment as needed
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Coordinate calibration and maintenance of production and quality assurance equipment
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Participate in manufacturing process validations as needed
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Assist Quality Engineer (QE) in root cause investigations for non-conforming parts
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Work with Quality Engineer to help resolve internal and external audit corrective and preventative actions
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Support the Quality Engineer in the performance of vendor assessments and recommendations
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Fulfill back-up duties as needed for the Quality Engineer
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Track MRB metrics to direct workload for MRB team
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Contact vendors to address quality concerns
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Direct the day-to-day activities of all QC s
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Ensure the safety and well-being of all Quality associates
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Maintain regular and punctual attendance.
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Comply with all company policies and procedures.
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Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

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Must have strong work ethic.
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Excellent oral and written communication skills required.
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Inventory management knowledge
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Ability to read and interpret design criteria including technical drawings, blueprints, and manufacturing instructions required
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Must be competent with using basic precision inspection tools
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Attention to detail is required.
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Effective conflict resolution.
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Analytical & problem-solving skills & ability to multi task.
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Solutions-oriented problem solver.
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Excellent planning, communication and organizational skills.
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Ability to effectively interface with different departments within the company.

Qualifications (Experience and Education)

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Able to execute at a project + strategic planning level.
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No/minimal supervision required, able to make decisions.
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Will be able to mentor/train junior staff members.
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Associates degree in a technical discipline, preferred.
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6+ years of experience in quality assurance, required. Preferably in medical device manufacturing.
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2+ years experience in a manufacturing leadership role, preferred.
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Advanced knowledge/proficiency Microsoft Office, required.
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Advanced Excel skills, required.
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A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

We thank all applicants in advance for their interest in the position. However, only those selected for an interview will be contacted.

Inogen is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally
protected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm;
http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf.

The pay transparency policy is available here: http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf.
Inogen is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@inogen.net or call (972) 616-5668 and let us know the nature of your request and your contact information.

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