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Aspen Surgical · 2 months ago

Quality Technician (2nd Shift)

Caledonia, MI 49316, USA

Full-time

Onsite

Mid Level

3+ years exp

Aspen Surgical is a company dedicated to creating exceptional products that make a lasting impact on people's lives. The Quality Technician will ensure that products and materials conform to regulatory and customer requirements, performing various quality control activities and supporting continuous improvement initiatives.

Health Care

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

Qualification

Quality improvement projectsFDAISO requirementsRoot cause analysisTechnical prints analysisProject ManagementComputer SkillsCommunicationFlexibilityAdaptabilityTeamworkProblem Solving

Required

High School Diploma or equivalent

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