Overview
OP Receiving Inspector Jobs in Wichita, KS at Cox Machine, Inc.
About Us:
Critical Innovations is currently developing multiple medical devices toward regulatory clearance. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. To date, the company has worked under more than 40 different Department of Defense awards from all military branches charged with medical technology development (i.e. U.S. Army, Air Force, Navy, and Space Force), including such agencies as the Air Force Medical Support Agency; Army Medical Research and Development Command; Defense Health Agency; and, Office of Naval Research. Contract types have included Small Business Innovation Research (SBIR), Joint Warfighter, Congressionally Directed Medical Research Programs, and Other Transactional Authority. As a prime contractor, Critical Innovations has a 99.5% rate of on-time program deliverable achievement. For Phase II awards, the company has 100% transition rate to Phase III funding. As a fully turnkey company, Critical Innovations possesses all the necessary capabilities and experience to guide a product seamlessly from proof-of-concept through to manufacturing, regulatory clearance, and commercialization.
Winner of the MTEC 2020 Prototype of the Year Award, Critical Innovations LLC is an ISO 13485:2016 certified, 21 CFR§820 QSR (cGMP) and DCAA compliant, medical research and development company focused on creating cutting-edge solutions to health threats that span the pre-hospital, hospital, and military environments. The FDA-registered small business employs an iterative development methodology focused on agile engineering to rapidly advance products.
Position Title: Quality Engineer
Overview
The Quality Engineer is instrumental in establishing and upholding quality control measures throughout our production processes, applying best practices to ensure that materials, components, processes and manufacturing techniques are used to produce high quality and reliable products.
This role entails close collaboration with the R&D, Engineering and Production teams to create and execute impactful quality assurance strategies from the initial receiving phase to the release of the final product.
The Quality Engineer’s responsibilities fall under two main areas:
1. Directs the effective development, implementation and continuous improvement of the organization’s quality assurance policies and procedures.
2. Assures that the Quality Management System is in compliance with medical device standards (ISO13485) and global regulations
The Quality Engineer will assist in the management and implementation of the Quality Management System to ensure compliance with ISO 13485 and the FDA’s Quality System Regulations 21 CFR Part 820, including development of process verification and validation, risk management and process optimization.
The Quality Engineer will provide additional support to the Quality Management System’s activities as assigned at the discretion of management.
This is an on-site, full-time position.
Reports to:
Vice President of Quality Assurance & Regulatory Affairs.
Duties and Responsibilities:
The Quality Engineer’s responsibilities typically involve:
· Collaborate with the R&D, Engineering and Production teams to establish necessary controls and verification/validation procedures for production processes.
· Develop and implement manufacturing process controls, including in-process inspections and sampling plans for receiving in-process, and final inspection.
· Lead process validation efforts to ensure consistency and reliability in manufacturing outputs.
· Author process verification/validation protocols and reports.
· Design and improve metrology and inspection techniques for components and subassemblies and finished good products.
· Collaborate with the production, and development & engineering teams to develop and maintain the risk management program for the manufacturing processes.
· Work closely with Engineering to develop best practices for various inspection methods, equipment, fixtures, and techniques.
· Create and maintain documentation related to quality processes, policies, reference procedures and work instructions in compliance with ISO 13485 and the FDA’s Quality System Regulations.
· Analyze quality data and metrics to identify trends and areas for improvement.
· Responsible for leading the efforts in root cause analysis, corrective action plans and implementation for quality issues.
· Ensure compliance with Critical Innovation QMS requirements, quality objectives, and relevant industry standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, Sherman law ).
· Support internal audits and external audits as needed.
· Provide support for any external and regulatory audits as required.
· Train production staff on quality procedures and best practices.
· Perform data trend analysis to rigorously assess and monitor the quality performance of products and processes as an integral part of the improvement process.
· Lead, participate in, or coordinate Corrective/Preventive Actions, investigations and root cause analysis as assigned.
· Lead or assist in quality evaluation of returned products and customer complaints as assigned.
· Evaluation of changes to design and/or manufacturing process for impact to the Design History File. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation.
· Additional support for the Quality Management Systems activities as assigned.
· On a daily basis, assess overall workload for any area that needs help, and assist coworkers and provide backup as needed without being reassigned by management.
Skills and Experience:
· Strong understanding of quality management systems and regulatory requirements in medical device manufacturing- (ISO 13485:2016, FDA 21 CFR 820).
· Experience with process validation, statistical process control, and measurement system analysis.
· Proficiency in quality tools and methodologies (e.g., Kaizen events, Lean Manufacturing, FMEA).
· Excellent analytical and problem-solving skills.
· Strong communication and interpersonal skills.
· Ability to work effectively in a cross-functional team environment.
· Good analytical skills and collaborative style.
· Ability to manage and report on project.
· Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
· Adaptability and resourcefulness to roll up sleeves and multitask in order to thrive in a global company environment.
· Highly organized and detailed oriented.
· Effective communication (both written and spoken).
· Able to perform physically demanding work such as lifting and moving equipment, and standing for long periods
Education and Training:
· Bachelor’s degree in engineering, Quality Assurance, or a related field.
· 7+ years of experience in quality engineering, preferably in the medical device industry.
· ASQ certification (CQE, CQA, or similar), preferred.
· Experience with CAD software and GD&T principles.
· Familiarity with automation and Industry 4.0 concepts.
· Authorization to work in the United States indefinitely without restriction or sponsorship.
*Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans’ status, or any other characteristic protected by law.
* To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.
Work Remotely
No
Job Type: Full-time
Pay: $105,000.00 – $150,000.00 per year
Benefits:
401(k)
Dental insurance
Flexible schedule
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Application Question(s):
Will you be able to reliably commute or relocate to Los Angeles for this job?
Education:
Bachelor’s (Required)
Experience:
Quality engineering: 7 years (Required)
Work Location: In person
Title: OP Receiving Inspector
Company: Cox Machine, Inc.
Location: Wichita, KS
