Quality Technician (2nd Shift)

Talent Acquisition Team•Caledonia, MI

27d

About The Position

We love what we do! At Aspen Surgical we live our values of Customer Focus, Accountability, Collaboration, Innovative Spirit, and Integrity 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. Do you want to be appreciated for your hard work? Be a member of a dynamic, fast-growing organization? View your job as a joy rather than a burden? Then we have a position for you! Summary: The purpose of this role is to ensure Aspen manufactured products and materials conform to specified regulatory and customer requirements. Evaluate, investigate, contain, and disposition nonconforming products identified by internal monitoring or customer feedback.

Requirements

High School Diploma or equivalent
3+ years of experience responsible for Quality improvement projects preferred
3+ 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. Computer Skills – Excellent computer skills including but not limited to Microsoft Office Suite, IFS, EtQ
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 with FDA Quality System Regulation, ISO 13485, European Union Medical Device Regulations, and MDSAP participating countries regulations

Responsibilities

Support validation and risk build activities with manufacturing and engineering group
Perform Customer Complaint Investigations, including customer complaint product dispositions and being the point of contact for quality related customer communications
Perform root cause analysis, identify solutions and implement effective corrective action for internal nonconformances, customer complaints and CAPA’s
Initiate non-conforming dispositions
Initiate CR’s and CO’s
Write, train and ensure the proper implementation of Quality Alerts, rework instructions and planned deviations.
Maintain, review, and make updates to manufacturing and purchasing Control Plans in IFS
Maintain relationships with suppliers and actively drives continuous improvement
Participate with Supply Chain in supplier selection process and purchased materials cost reduction
Perform FAI for new product and product changes
Maintain supplier quality files and performs audits as necessary per the QMS
Continuously identify areas of improvement in the manufacturing processes to ensure compliance or that would enhance product quality and partner with manufacturing to implement the improvements
Analyze improvement opportunities through MRB monitoring
Develop trainings to build quality awareness
Support manufacturing and engineering to resolve technical issues