Quality Technician (2nd Shift)

Aspen Surgical; Caledonia (MI); On-site; USD 70,000 - 95,000; Full time

Job summary

Aspen Surgical in Michigan is seeking a Quality Improvement Specialist to lead validation, risk assessment, and CAPA activities within a regulated medical device environment. You will investigate customer complaints, perform root cause analyses, and coordinate with manufacturing and suppliers to drive continuous quality improvements in line with FDA and ISO requirements.

Collaborating with cross-functional teams, you will also develop trainings and help sustain a compliant quality management

Qualifications

• 3+ years experience improving quality in regulated environments.
• Experience with FDA and ISO requirements preferred.
• Strong communication and interpersonal skills at all levels.
• Ability to read and analyze technical prints and drawings.
• Effective root cause analysis and corrective actions.
• Project management skills to handle multiple projects.

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 CAPAs.
• Initiate non-conforming dispositions.
• Initiate CRs and COs.
• Write, train and ensure the proper implementation of Quality Alerts, rework instructions and planned deviations.
• Maintain, review, and updates to manufacturing and purchasing Control Plans in IFS.
• Maintain relationships with suppliers and actively drive 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 perform 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.

Skills

Communication

Leadership

Teamwork

Problem solving

Project management

Technical reading

Adaptability

Decision making

Education

High School Diploma or equivalent

Tools

Microsoft Office

IFS

EtQ

Job description

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 CAPAs
• Initiate non-conforming dispositions
• Initiate CRs and COs
• 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 drive 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 perform 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

What You Need to Succeed in This Position

• 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

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 with FDA Quality System Regulation, ISO 13485, European Union Medical Device Regulations, and MDSAP participating countries regulations

Physical Requirements

NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation

Please refer to Essential Duties and Responsibilities.

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