Have you or a family member been impacted by cancer?  Would you like to make a difference in the lives of cancer patients and their families?  Then, Qfix is the answer.

Our medical products are designed and manufactured to precisely position the cancer patient when receiving radiation therapy.  This precision helps to ensure that the radiation hits the cancer cells and not the healthy cells.

Qfix is an innovative medical device company located in Avondale, Pennsylvania, focused on discovering, developing and commercializing technology-driven solutions for radiotherapy patient positioning. We foster a deep engagement with medical professionals to design and innovate patient positioning solutions.  Our products have been making patient lives better in over 70 countries. 

Come join our team today! 

www.qfix.com/careers

Job Summary: 

The Senior Quality Engineer position is responsible for analyses, metrics, and continuous improvement 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.  Leads continuous improvement activities with cross-functional team members, including root cause analysis, corrective and preventative actions, verification of effectiveness, First Article Inspections, product and process improvements.   Collaboratively develop product specifications, new product design, verification and validation, design control documentation, risk management, process development, and post-market activities.  The Senior Quality Engineer leads investigations for internal and vendor non-conformances, complaints, Medical Device Reports (MDR), Recalls, and all Adverse Event reports in accordance with Qfix procedures, and regulatory requirements. The Senior Quality Engineer will interact with machine and design engineering, regulatory, marketing, customer service, customers, medical professionals, and management. 

Job Details: 

•    Drives a work environment of continuous improvement that supports Qfix’s Quality Policy, Quality System, and the appropriate regulations.  
•    Communicates business-related issues or opportunities for improvement to management immediately.
•    Accountable for compliance with applicable US and International regulations and directives including, but not limited to, Food & Drug Administration (FDA), Canadian and European Union Medical Device Regulation (MDR) regulations.  
•    Subject Matter Expert – Technical and Quality Management System
•    Trains/mentors junior team members effectively
•    Ability to lead and mentor teams
•    Lead process projects
•    Lean Manufacturing, lead waste reduction
•    Lead ISO 13485:2016 Auditor
•    Advanced root cause analysis and corrective action skills
•    Ability to identify trends in metrics and action trends
•    Extensive knowledge of all Quality Management System elements
•    Develops metrics and works in a team environment to drive metric achievement. 
•    Collects follow up information related to complaints from customers and appropriate stakeholders, such as medical professionals or field staff to obtain information pertinent to investigations.  Prepare responses to customers and field as necessary per process. 
•    Collaborate with engineering and manufacturing to disposition product during daily meetings.
•    Analyze non-conformances, CAPAs, complaints, RMAs, and relevant quality data.   Support management review.
•    Perform proactive data analysis, testing, simulation testing, and root cause investigations and resolution to support the highest product quality, patient safety, and customer satisfaction.  
•    Ensure timely, accurate and complete investigations to comply with FDA requirements and other regulatory bodies and countries.
•    May be required to perform customer visits to assist in the investigation of critical issues and customer concerns. 
•    Participate in New Product Design process as a Quality Representative to ensure that requirements are met per documented procedures and customer needs. 
•    Work with production during Design Transfer phase to ensure that products and processes meet all quality requirements.
•    Leads or participates in Risk Management Activities.  Must be able to identify new risks and execute the process.
•    Support manufacturing engineering in process quality improvement activities, including statistical process control, development of sampling plans, and Design of Experiments (DOE).
•    Assist in the development and implementation of quality system, production, calibration, inspection, and maintenance procedures as required.
•    Perform Verifications & Validations of Processes, Equipment, and Test Methods as required.
Coordinate and lead internal and supplier qualification audits as required. 
•    Maintenance of Quality procedures.
•    Remain current on all required training.
•    Perform additional duties as assigned by the Director of Quality

Position Requirements: 

•    Minimum of a 4-year degree in engineering, technical, or life sciences from an accredited university or college.
•    Minimum of five years’ experience in Medical Device Industry
•    ISO 13485:2016 experience
•    Lean Manufacturing 
•    Six Sigma certification preferred
•    Independent analytical and problem-solving skills
•    Leadership skills
•    Project leadership 
•    Demonstration of a successful track record in the Medical Device Industry
•    Trains/mentors junior team members effectively
•    Ability to lead and mentor teams to execution/implementation
•    Excellent written and oral English communication skills required, including technical writing skills. MS Office Suite (Word, PowerPoint, and Excel) experience required. 
•    Statistical analysis
•    Ability to communicate effectively with individuals and teams.
•    Must be able to manage multiple tasks performed with accuracy and a high attention to detail.