Quality Engineer

Talent Acquisition Team•Caledonia, MI

51d

About The Position

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:

Requirements

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
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
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

Nice To Haves

ASQ certification a plus
IFS experience preferred

Responsibilities

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