Quality Assurance Specialist, Req 2021-01MPI
Company Overview: Medical Positioning, Inc. (MPI), based in Kansas City, KS is a subsidiary of Altimate Medical Holdings Inc. (AMHI). AMHI designs, develops, and commercializes durable medical equipment and is focused on improving and maximizing the wellbeing of our customers. AMHI employees strive to uphold our values of Quality, Customer-centric, Teamwork, Integrity, Innovation, and Community. AMHI is privately owned by Granite Partners, a mission-driven private investment and holding company that combines long-term business growth with a dedication to community well-being and their employees.
MPI was founded in 1988 as American Echo with the release of our flagship product, the EchoBed®. The first of its kind, the EchoBed® revolutionized sonography ergonomics, spearheading a specialty imaging table market with the introduction of a drop away section, known today as the Imaging Drop Section. This innovation allows for unhindered ergonomic access to the apical view during echocardiograms, reducing the risk of Repetitive Stress Injury (RSI) for sonographers, improving patient comfort, and facilitating faster, more accurate imaging.
Today, MPI’s product portfolio includes ergonomic and bariatric diagnostic imaging platforms designed to offer optimum positioning and improved imaging results across cardiology, vascular, radiology, breast biopsy, surgery, pain management, and speech pathology. With 20+ employees across all functions including Supply, Assembly, Finance, Engineering, Sales and Support, MPI provides an intimate, customer centric experience creating a distinct marketplace advantage.
MPI is looking for a Quality Assurance Specialist to assist with the maintenance of an established Quality Management System (QMS) which conforms to and is compliant with the Food & Drug Administration Quality System Regulation (FDA QSR), ISO 13485 Standard, and other applicable regulations/standards. Primarily responsibilities will include calibration & equipment management, incoming receiving inspection, disposition of non-conforming materials, returns, parts validations, addressing non quality related complaints, ensuring appropriate work environment is maintained, final inspection of product, and auditing. This position will be reporting into the Quality Manager / QMS Rep for the family of AMHI companies.
Specific Job Duties/Responsibilities:
- Assist Document Control with the maintenance and development of site-specific documentation
- Assist Document Control in ensuring proper records are maintained appropriately to provide evidence of conformity to requirements.
- Management Responsibility
- Management Review
- Participate in Management Review meetings with Top Management to ensure the continued suitability, adequacy, and effectiveness of the QMS
- Management Review
- Resource Management
- Communicate any resources needed to maintain the effectiveness of the QMS and/or meet regulatory or customer requirements to the QM/QMS Rep.
- Assist with conducting on-site training and assist Document Control in the maintenance of training records on QMS processes/procedures and assess competence where needed or coordinate with designee for that training as applicable.
- Assist the Quality Assurance Manager in working with Supply Chain to ensure appropriate Infrastructure exists and appropriate records are maintained, and that necessary Work Environment and Contamination Controls are in place to not adversely affect product quality.
- Product Realization
- Assist the QM/QMS Rep in working with Product Support Specialist related to customer feedback, including complaints, review cases, and initiate CAPAs as needed.
- Assist the QM/QMS Rep and Purchasing in working with suppliers on quality issues and assist them in completing corrective actions.
- Assist Purchasing in completing supplier evaluations (as needed)
- Conduct verification of purchased product (inspection) as applicable and maintenance of records (with assistance from Supply Chain as needed).
- Ensure proper identification (status labels) of incoming components
- Ensure that final product conforms to specification and is clean by performing Final Inspection
- Work with Supply Chain and Finance to ensure proper Identification, Traceability, processing storage, handling and distribution of product.
- Monitoring and Measuring Equipment
- Performs or works with Quality Assurance Manager, Supply Chain and Product Development for calibration and maintenance activities.
- Assist in determining remedial action when equipment is found to be damaged or inaccurate.
- Measurement, Analysis, and Improvement
- Assist the QM/QMS Rep in gathering and analyzing information relating to satisfaction of customer requirements.
- Assist the QM/QMS Rep and Product Support Specialist in review and investigation of customer complaints.
- Internal Audits
- Conduct Internal Audits
- Assist the QM/QMS Rep Follow up on findings and assist with initiating a CAPA (if applicable) and verification of actions taken.
- Non-Conforming Product
- Assist Product Development and Supply Chain with identification and control of Nonconforming product and the completion of NCM reports.
- Review non-conforming material reports, log, and Supplier Corrective Action requests
- Capture and process records (RMAs, receivers, nonconforming materials, modify/update purchase orders)
- Analysis of data
- Assist the QM/QMS Rep in collection and analysis of data to demonstrate the suitability, adequacy, and effectiveness of the QMS.
- Identify, or assist in the identification/implementation of, process and QMS improvements.
- Corrective and Preventive action (CAPA)
- Assist the QM/QMS Rep in managing requests, including initiating, investigating (including root cause analysis), implementing, and verifying.
- Assist suppliers in completing supplier corrective actions/work with suppliers on any quality issues.
- QST Member (Quality Steering Team)
- Shares information regarding quality assurance/quality control issues
- Attend Management Review meetings
- Update the site bulletin board after each management review meeting
- Other duties as assigned.
Education and/or Experience:
- Associates or Bachelor’s Degree preferred
- 1+ years of experience working in QA preferred
Skills and Abilities:
- Ability to follow procedures and apply to MPI products and processes
- Ability to read and follow product design prints
- Detail oriented
- Communication skills – oral and written
- Ability to trouble shoot and solve problems
- Ability to work independently.
- Ability to work individually and as part of a team
- Ability to work with teams in multiple locations
- Computer proficiency with Microsoft Office and ability to learn other software
- Thorough product and process knowledge (internal training will be provided)
- Knowledge on use of common hand/power tools and measuring devices
- Receive and inspect incoming product/materials.
- Release final product for shipping.
- Identify and handle disposition of non-conforming product per procedures.
- Initiate and implement corrective and preventive actions.
- Stop production if any process adversely affects product quality.
- Have the authority to identify and evaluate quality issues in their position and to initiate, recommend and provide effective corrective actions to any quality problem.
- Stop production if any process/condition poses a safety hazard.