Quality Coordinator

SMC Ltd.•Somerset, WI

About The Position

Responsible for organizing and moderate quality assurance and control activities to ensure products and services meet organizational and regulatory standards. Manage customer required data documentation, Material Review Board (MRB) records with dispositions, product inspections, and implement quality improvement initiatives. Provides support as a technical resource for departmental activities and requirements.

Requirements

High School Diploma or equivalent required.
Knowledge of Quality Management Systems (ISO 13485, 9001)
Diligence and ability to manage multiple tasks.
Strong mathematics skills, basic knowledge in statistics, and mechanically inclined.
At least 2 years of experience in a quality function
Strong training, communication, and computer skills.

Nice To Haves

Experience in a Medical Device or Pharmaceutical regulated industry a plus.
ASQ certification a plus; CQE, CQM, CQA
Problem solving training a plus; Six-Sigma Black/Green Belt/Lean-Kaizen

Responsibilities

Prepare, redact, and transmit customer required product release documentation such as Device History Records, Inspection Records, and engage with Customer portals such as Supplier Quality Management (SQM)
Perform accurate review and closure of Batch History Records (BHR) and Device History Records (DHR), including yield, reconciliation, Out of Specification reports, and Material Review Board reports for medical and pharmaceutical products.
Engage with the Documentation Control Department to ensure all records are accurate, up-to-date, and accessible. This collaboration maintains regulatory compliance, supports quality assurance through strict version control, and creates reliable audit trails for organizational activities.
Maintain the integrity of the Material Review Board systems compliance for suspect and nonconforming products.
Perform proper containment and initiate MRB records for identified product impacted, Engineering Change orders (ECO’s); i.e. Rev Change, Relabeling.
Lead and / or attend daily MRB meetings and connect with product subject matter experts for verification of disposition.
Work with a cross-functional team to evaluate and assess adverse effects through the MRB process.
Document and oversee disposition activities for MRB records within ERP system, ensuring completeness, accuracy, and timeliness of actions and closure.
Complete MRB related paperwork, verify, stamp, scan, and save to MRB library finalizing the MRB closure procedure.
Training in-process inspectors on measurement methodology and standard operating practices as directed.
Approve ECO’s for on hold/off hold parts and tools that are unavailable for production or shipment.
Serve as a backup to other quality roles.
Ensure data is collected and retained to the company policies and procedures.
Maintain a working knowledge of industry quality assurance codes and standards.
Work with production to resolve quality issues, Quality Alerts, and verify documentation is complete.
Assist in the verification and closure of Maintenance Repair Orders (MRO’s).
Raise awareness of customer complaints and contribute to complaint reduction.
Participate in Corrective Action and Preventative Actions to investigate nonconformities.
Proficient knowledge of Good Documentation and Good Manufacturing Practices.
Organize problem solving in the areas of scrap, process capability, etc.
Conduct system and product audits.
Regular attendance and occasional overtime.
Other duties as assigned.