Quality Technician (2nd Shift)

Aspen Surgical; Caledonia (MI); On-site; USD 65,000 - 95,000; Full time

Job summary

Aspen Surgical in Michigan is seeking a quality professional to improve processes and ensure regulatory compliance. You will support validation and risk activities with manufacturing and engineering, investigate customer complaints, and drive CAPA efforts across the organization.

You will analyze root causes, implement corrective actions, initiate dispositions and CRs/COs, and maintain control plans with IFS. Strong collaboration with suppliers and cross-functional teams is essential.

Qualifications

• 3+ years of experience responsible for quality improvement projects preferred.
• 3+ years of experience in a regulated industry with FDA and ISO requirements preferred.
• Ability to read and analyze technical prints and drawings.
• Experience with root cause analysis and corrective actions.

Responsibilities

• Support validation and risk build activities with manufacturing and engineering group.
• Perform Customer Complaint Investigations and communicate quality related to customers.
• Perform root cause analysis and implement effective corrective actions.
• Initiate non-conforming dispositions, CRs and COs.
• Write and train on Quality Alerts, rework instructions and planned deviations.
• Maintain and update manufacturing and purchasing Control Plans in IFS.
• Drive supplier quality improvements and participate in supplier selection and cost reduction.
• Perform FAI for new product and product changes.
• Audit supplier quality files and perform necessary audits per the QMS.
• Identify and implement manufacturing process improvements to ensure quality.

Skills

Quality improvement

Root cause analysis

CAPA management

Cross-functional teamwork

Regulatory awareness

Project management

Communication skills

Technical reading (prints, drawings)

Education

High School Diploma or equivalent

Tools

Microsoft Office Suite

IFS

EtQ

Job description

In This Position, You Will Have the Opportunity to

• 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

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

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.