The Sustaining Quality Engineer will primarily be responsible for quality management related to operational/design sustaining activities and engineering change management. As a member of a cross-functional team, he/she will ensure that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Sustaining Quality Engineer applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization.
Essential Job Functions
· Lead Sustaining Quality Engineering activities in relation to engineering change management including changes to material, design, or suppliers and associated technical drawings and specifications, process and equipment re-validations (IQ OQ PQ), aging/stability studies, sterilization & biocompatibility impact, ERP systems and other.
· Identify and support quality activities associated with process and cost improvement projects.
· Perform root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA/SCAR systems as needed to structure activities.
· Support teams in the presentation of objective evidence of conformity during audits.
· Use appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making.
· Understand and manage work to minimize cost of quality throughout a product’s lifecycle.
· Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented for product changes.
· Implement control measures and drive resolution when supplier quality issues are identified.
· Create, track, and implement supplier scorecards in collaboration with Operations.
· Apply supplier management principles such as supplier selection, qualification, certification, and performance improvement.
· Apply the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interpret and select variable, attribute, and zero-defect sampling plans.
· Develop and validate test methods. Identify and apply metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conduct measurement system error studies such as Gage R&R.
· Understand the implementation of appropriate internal, national and international requirements and standards.
· Define, identify, and apply product and process control methods such as developing control plans, identifying critical control points, and developing and validating work instructions.
· Contribute to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas such as those identified in this position description.
· Perform other duties as assigned.
· Requires a bachelor’s degree in a STEM discipline and minimum 3+ years’ experience in the medical device or pharmaceutical field.
· Manufacturing experience a plus.
· Technical knowledge and understanding of the medical industry.
· Aptitude and willingness to learn.
· Experience in 3D modeling and drafting preferred.
· Strong verbal and written communication skills.
· Foster a positive culture of growth, collaboration, and achievement across the organization. Responsible to live and exemplify Safeguard Medical’s DNA Strands.
· Must be able to work in a rapid-paced changing environment.
· Exceptional organizational and interpersonal skills are required.
· Self-directed, demonstrating ownership and accountability
· Demonstrates the ability to plan, execute, control and deliver on project tasks and overall goals
· Strong written and verbal communication skills
· Team-oriented personality with the ability to lead and influence others effectively while creating and maintaining a positive environment
· Ability to develop and maintain relationships with medical professionals, sales force, and cross functional team members
· Understanding of change management, conflict resolution and team dynamics
· Excellent problem-solving skills, including experience implementing the DMAIC thought process and structured root cause analysis
· Ability to identify project and design risks and create mitigation strategies
· 3D modeling and print creation
· Ability to independently make sound decisions with available information
· Ability to analyze data using statistical methods; MiniTab experience preferred
· Experience with sterilization and packaging validation activities preferred
Performing the duties of this job regularly involves: sitting, standing; walking; hearing/listening, repetitive hand movement; vision requirements - close vision, adjust focus, color code.
This position requires the ability to: maintain an appropriate work pace; comprehend and follow instructions; exercise logic and reasoning; organize and prioritize; read; compose written communication; communicate verbally; problem solve make decisions; count and compute, analyze and interpret data; multi-task/re-direct and experience numerous interruptions,. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations
Limited domestic & international travel occasionally. (<15% travel time)