What are the responsibilities and job description for the Quality Assurance Engineer - Medical Devices position at CAI?
Job ID NumberR4753Employment TypeFull timeWorksite FlexibilityOnsiteJob SummaryAs the Quality Assurance Engineer you will be responsible for non-conformance resolution, analysis and trending of data, receiving inspection and product release activities, auditing to regulated standards, maintenance of documentation, and generating test protocols and reports with little or no supervision.Job DescriptionWe are looking for a Quality Assurance Engineer to focus on application of quality system regulations and their application to medical devices. This position will be a full-time 3 month contract and onsite.What You'll Do Lead in the execution of the NCR, Complaint, and CAPA systems to ensure effective resolution to issues and timely completion of actionsUse statistical tools (Minitab, etc.) to analyze data, make acceptance decisions, and improve process capabilityProvide technical and statistical support in evaluating products from a quality and reliability standpointLead and / or assist in quality system audits to ensure compliance with internal / external standardsLead and / or assist the organization toward continuous quality improvement through training and implementation of quality improvement toolsAssist in the continuous improvement of the Quality Management System through auditing, trend analysis / escalation, and the review / revision of documented proceduresPerform quality assurance activities as assigned including inspection, product release, and product testingInteract with cross-functional personnel to ensure that new products are smoothly transitioned from development to manufacturingPerform measurement system analyses to evaluate / improve test and inspection equipmentOther responsibilities as defined by the ManagerWhat You'll NeedBachelor’s Degree with technical focus3-5 years minimum quality assurance experience in technical role2 years minimum medical device experienceKnowledge and application of quality system regulations and their application to medical devicesExperience in the use and understanding of measurement equipment and testing as it relates to tubingStrong Microsoft Office skills – Word, Excel, etc.Strong math skills with good understanding of advanced statistics (Gage RR, capability analysis, etc.)Self-motivated, efficient, ability to work with little or no supervision, and committed to a team approachStrong interpersonal, organization, and project management skillsPhysical DemandsAbility to safely and successfully perform the essential job functions consistent with the ADA and other federal, state and local standardsSedentary work that involves sitting or remaining stationary most of the time with occasional need to move around the office to attend meetings, etc.Ability to conduct repetitive tasks on a computer, utilizing a mouse, keyboard, and monitorReasonable Accommodation StatementIf you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employment selection process, please direct your inquiries to application.accommodations@cai.io or (888) 824 – 8111.Equal Employment Opportunity Policy StatementIt is the policy of CAI not to discriminate against any employee or applicant due to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or being a protected veteran. It is also the policy of CAI to take affirmative action to employ and to advance in employment, all persons regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or being a protected veteran, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment. Employees and applicants of CAI will not be subject to harassment due to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or being a protected veteran. Additionally, retaliation, including intimidation, threats, or coercion, because an employee or applicant has objected to discrimination, engaged or may engage in filing a complaint, assisted in a review, investigation, or hearing or have otherwise sought to obtain their legal rights under any Federal, State, or local EEO law is prohibited.
