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Quality Assurance Engineer I

3 months ago

Orange City, United States CIVCO Radiotherapy Full time

Medical, Dental, and Vision coverage starts on Day OneFree: life insurance, short and long-term disability insurance, Telehealth Appointments, and Employee Assistance Program. Immediate vesting of 401(k) matching. Generous PTO and 11 Paid Holidays a year.And, most importantly... truly meaningful workWould you like to make a difference in the lives of cancer patients and their families? We design and manufacture radiation oncology medical devices to ensure more accurate, comfortable treatment for cancer patients. CQ Medical is the global market leader in patient positioning.As an innovative medical device company, we focus on discovering, developing, and distributing technology-driven solutions to improve outcomes for radiotherapy patient positioning. www.cqmedical.com/careersEssential Duties and Responsibilities include the following. Other duties may be assigned.Primary ResponsibilitiesResponsible for establishment, implementation and maintenance of the Product Development, Design Control, Risk Management and Process Validation process while ensuring alignment with appropriate regulation and business objectives.Responsible for driving improvements in supply chain performance for existing suppliers and ensuring appropriate qualification of new suppliers.Supports complaint, NCMR, CAPA, RMA/Servicing, market surveillance, and internal audit processes as required including ensuring appropriate actions are being executed for investigation, containment and escalation activities.Drive continuous funnel of process productivity improvement projects.Support audits and ensure execution of corrective action, verification of effectiveness, and compliance with customers' specifications.Develop supplier audit plans and perform evaluations of new and existing suppliers, including audits of special and contract manufacturing processes.Responsible for quality deliverables associated with product development and process validation activities in alignment with appropriate regulations and business objectives.Responsible for process and product quality with appropriate regulations and operations objectives.Support for defining requirements for QMS Software validation and ensuring validations are executed and kept up to date. Owner of site specific QMS validations as required.Maintain visibility to defect rates and work with supplier to improve and maintain part quality.Establish expertise in special processes required to execute business objectives, for example cleanroom qualification and operation and sterilization processes.Responsible for quality control and inspection including development and implementation of inspection and sampling plans.Development of alignment of between site inspection processes, sampling plan, equipment, and tools.Responsible for calibration at Iowa site as well as coordination of best practices with other sites.Communicate safety and/or business concerns and opportunities for improvement to Executive Management immediately.Identify Quality opportunities for improvement, develop training, and train all team members to deliver value to the customer and incorporate quality into daily work.Support regulatory with Medical Device Reports (MDR), and all Adverse Event reports, recalls and assist with health hazard activities as required. May be responsible for coordination of on-site recall activities.Able to establish and communicate rationale for quality initiatives.Able to clearly communicate objectives, actions, and owners cross-functionally.Attend all relevant training and actively pursues further training/education.Subject matter expert in relevant medical device standards.Supervisory Responsibilities May be asked to train, supervise, and/or mentor others within Quality as required. Responsible for employee development including actionable development plans.Communication of development activities with the management team.Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Required Education and/or ExperienceBachelor's degree in engineering or related field.Preferred 2+ years of experience in quality and/or engineering in the medical device industry experience with working knowledge of medical device regulations (such as ISO 13485 and ISO 14971) in the United States and in international markets.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)