Iso 11607 Jobs in Wisconsin (NOW HIRING)

... ISO 11607) • Experience with controlled manufacturing environment (CME) or cleanroom assembly operations (ISO Class 7/8) • Statistical analysis skills (Minitab or equivalent); SPC, process ...

Ensure compliance with ISO 13485, ISO 11607, and internal procedures. Production & Shift Execution Own end-to-end shift operations, including staffing, production flow, and issue resolution.

Ensure compliance with ISO 13485, ISO 11607, and internal procedures. Production & Shift Execution Own endtoend shift operations, including staffing, production flow, and issue resolution. Supervise ...

Ensure all new packaging designs and processes meet medical device packaging standards and regulations (e.g., ISO 11607, FDA QSR, ISO 13485). Lead development of design verification and validation ...

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Experience with ISO 13485 and ISO 11607 standards. Experience with Measurement System Analysis. Experience with Minitab statistical analysis software. Experience with root cause analysis. Medline ...

Ensure all new packaging designs and processes meet medical device packaging standards and regulations (e.g., ISO 11607, FDA QSR, ISO 13485). Lead development of design verification and validation ...

Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607 * Support manufacturing units with analyzing failures, preventive and corrective ...

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607 * Support manufacturing units with analyzing failures, preventive and corrective ...

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Responsible for coordinating and implementing the quality activities as directed by the Quality Manager for the ISO/TS Quality Management System. * Responsible for responding to quality issues within ...

Follow all established procedures in compliance with FDA and ISO 13485:2008 standards. * Maintain documentation in accordance with GMP and company policies. * Adapt to various inspection assignments ...

Leads and/or participates in the development, implementation, compliance, and maintenance of standards (FDA, ISO 13485:2016, etc.) and procedures. * Acts as a direct contact for FDA. Ensures FDA ...

Leads and/or participates in the development, implementation, compliance, and maintenance of standards (FDA, ISO 13485:2016, etc.) and procedures. * Acts as a direct contact for FDA. Ensures FDA ...

In addition, ownership and involvement with the ISO 9001 Quality Management System / IQMS Quality module and internal audit process is required. Essential Job Duties/Responsibilities * Complete ...

Lead and continuously improve ISO 9001 & ISO 22000 Quality Management Systems * Oversee QC Lab operations, calibration programs, and test method development * Drive customer complaint resolution ...

Qualifications · Experience as a management representative for an ISO 9001 organization. · Experience with the Continuous Improvement, Quick Response Manufacturing (QRM), and the Lean or Six Sigma ...

Lead and continuously improve ISO 9001 & ISO 22000 Quality Management Systems * Oversee QC Lab operations, calibration programs, and test method development * Drive customer complaint resolution ...

Provide strategic guidance on ISO compliance and ensure alignment with standards. * Monitor and manage the quality action system to ensure timely resolution of issues. * Lead root cause analysis and ...