Work Address, Avondale, PA, USRequisition ID:
Qfix is an innovative medical device company focused on discovering, developing and commercializing technology-driven solutions for radiotherapy patient positioning. Our focus is to foster a deep engagement with medical professionals to design and innovate patient positioning solutions. We make it our business to listen closely to the needs of medical professionals and together we advance precise positioning solutions for cancer treatment. If you'd like the opportunity to work for an innovative, technology-driven company with a passion for making a difference in the lives of cancer patients and their families, Qfix is the answer.Job Summary:
The Quality Specialist is responsible for analyses and control of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR) and other regulatory guidelines. Facilitates all complaint investigation activities with cross functional team members and prepares complaint investigation reports and responses. Responsible for assisting with the inspection and testing of return samples and summarizing the findings to support complaint investigations. Drives continuous improvement activities with cross functional team members, including root cause analysis, corrective and preventative actions, verification of effectiveness, First Article Inspections, and product and process improvements. The Quality Specialist provides support and assistance in the evaluation of internal and vendor non-conformance, complaints, Medical Device Reports (MDR), and all Adverse Event reports in accordance with Qfix- procedures, and regulatory requirements. The Quality Specialist will interact with machine and design engineers, regulatory, marketing, and customer service representatives. In addition, interactions with customers, medical professionals, and management are integral. Job Responsibilities:
• Promoting a work environment of continuous improvement that supports Qfix's Quality Policy, Quality System, and the appropriate regulations.
• Assisting with communicating business related issues or opportunities that may need improvement to management quickly.
• Accounting for compliance with applicable US and International regulations and directives including, but not limited to, Food & Drug Administration (FDA), Canadian and European Union regulations.
• Working in a team environment to achieve metrics.
• Collecting follow up information related to complaints from customers and appropriate stakeholders, such as medical professionals or field staff to obtain information pertinent to the investigations. Prepares responses to customers and field as necessary per process.
• Collaborating with engineering and manufacturing to disposition product during daily meetings.
• Analyzing non-conformance, CAPA, complaint, and relevant quality data. Supporting management review.
• Performing data analysis, testing, simulation testing, and root cause investigations and resolution to support the highest product quality, patient safety, and customer satisfaction.
• Ensuring timely, accurate and complete investigations to comply with FDA requirements and other regulatory bodies and countries.
• Leading and supporting internal and external audits.
• Maintaining quality procedures.
• Remaining current on all required training.Job Qualifications:
• Strong analytical and problem-solving skills.
• Ability to interact with individual and groups at all levels, including healthcare professionals.
• Mathematical knowledge including algebra/statistics; utilization of sampling plans and statistical charts.
• Proven decision-making ability.
• Ability to use testing equipment.
• Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
• Analytical and problem-solving skills.
• Excellent written and oral English communication skills, including technical writing skills.
• MS Office Suite (Word, PowerPoint, and Excel) experience.
• Ability to interact effectively with individuals and teams.Job Requirements:
• High school diploma; Associate's degree in science / healthcare or equivalent technical degree is preferred.
• One to three years' work experience in a manufacturing environment.
• Medical Device and/or Regulated Industry is preferred.
• Please be prepared to submit a writing sample from your previous work experience. School experience in a related industry is acceptable.