Quality Engineer

About Aspen

We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people’s lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.

Summary

Quality Engineer is a key support role within the organization driving the oversight and execution of many tactical aspects of the QMS. This role includes a broad range of duties and responsibilities including but not limited to the following:

In This Position, You Will Have the Opportunity To

• Lead Customer Complaint Investigations
• Responsible for customer complaint product dispositions
• Perform root cause analysis and implements effective corrective action for customer complaints and CAPA’s
• Work with vendors to investigate nonconforming product issues, as necessary.
• Initiate non-conforming dispositions
• Support validation and risk build activities with manufacturing and engineering group
• Initiate CR’s and CO’s
• Develop and implements test methods and procedures for inspecting, testing and evaluating product and processes
• Continuously identifies areas of improvement in the manufacturing processes that would enhance product quality and partner with manufacturing to implement the improvements
• Assess quality performance using statistical and analytical methods
• Develop gauging methodology for products
• Perform capability studies and gage R&R
• Conduct trend analysis: collect data, create, update & maintain trend charts and reports
• Analyze improvement opportunities through MRB monitoring
• Support Quality Improvement Coordinators to ensure products & processes comply with regulatory and QSM requirements
• Develop trainings to build quality awareness
• Review and approves risk management/risk analysis documents
• Participate in PFMEA and DFMEA reviews
• Participate and provides input in design review meetings, partnering with NPD and Manufacturing during the entire development and transfer process
• Support manufacturing and engineering to resolve technical issues

What You Need to Succeed in This Position

• Bachelor’s degree in Engineering or a technical field preferred
• 3 years of experience responsible for Quality improvement projects preferred
• 2 years of experience in a regulated industry experience that includes FDA and ISO requirements preferred
• ASQ certification a plus
• Communication – displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels
• Flexibility and Adaptability – make effective decisions and maintain effectiveness under changing circumstances and priorities
• Teamwork, communication, positive attitude required to support the manufacturing environment
• Ability to read and analyze technical prints and drawings
• Problem Solving – able to perform root cause analysis and implement effective corrective actions
• Project Management – able to effectively manage and complete multiple projects simultaneously
• Conduct Process Failure Mode and Effect Analysis (PFMEA)
• Experience in 3D modeling, “Solidworks” preferred
• Computer Skills – Excellent computer skills including but not limited to Microsoft Office Suite. IFS experience preferred

Quality and Regulatory Requirements

• Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
• Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations

We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.