Zeus
Cathx Site Quality Lead
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Cathx Site Quality Lead
role at
Zeus
Responsibilities
Ensure the effectiveness and continuous improvement of the manufacturing site to ensure customer satisfaction and achieve the quality policy objectives.
Provide daily oversight to the Quality staff at the manufacturing site with the exception of the Design assurance engineers.
Ensure compliance with 21CFR820, ISO 13485, and EU MDR 2017/745 (the requirements) as applicable to CathX at the manufacturing site.
Oversee the following activities at the site for on-time completion and compliance with requirements:
Inspection, measuring and testing
Nonconforming materials
Complaints and RMA
Corrective and preventive action
Gemba walks and LPA
Equipment and process validation
Facility maintenance
Environmental monitoring and testing
Serve as the person most responsible for quality at the manufacturing facility, in the capacity of Deputy Management Representative when the Director of Quality is not present.
Support, compile, participate in and post monthly metrics and management reviews.
Oversee the IQC/ Metrology lab and provide direction on priorities for the Quality assurance unit (IQC) at the facility. The activities of IQC include:
Receiving Inspection
First Article Inspection
Testing & metrology
Final Inspection
Nonconforming Materials
Lot history record review
Lot release preparation
Preventive maintenance
Calibration
Ensure the output of the manufacturing site IQC/ metrology lab meets Top Management KPI and quality policy objectives.
Act as the primary audit contact for external audits at the direction of the Director of Quality.
Respond to customer survey and self-assessment requests at the direction of the Director of Quality.
Review quality agreements and no-change agreements from customers at the direction of the Director of Quality.
Lead problem‑solving initiatives and improvement activities as agreed with Top Management to resolve manufacturing site or systemic issues.
Provide input to Sustaining Quality and Design Assurance engineers at the manufacturing site on best practices.
Qualifications
BS/BA, or Engineering degree with a scientific or engineering emphasis required.
Seven or more years of work experience in a regulated medical device environment.
Previous experience managing and supervising engineers, technicians and inspectors.
Six sigma Green or Black Belt preferred.
ISO 13485:2016 Lead Auditor certification preferred.
Management and leadership training or certification is desired.
Competencies
Support the values of CathX including Excellence, People, Integrity, and Creativity.
Excellent verbal and written communication skills.
Commitment to customer satisfaction and communication.
Ability to facilitate the development of direct reports.
Ability to manage tight timelines and changing priorities.
Excellent problem‑solving techniques and ability to drive to root cause.
Proficient with Minitab software and other statistical software and data analysis.
Physical Demands and Work Environment
Physical Activity – Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
Physical Requirements – Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Visual Acuity – The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. Occasionally performing visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices.
Working Conditions – The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
The performance of this position will require exposure to the manufacturing areas, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing protection.
Travel This position may require up to 10% travel to other manufacturing facilities, suppliers, and customer locations as required, dependent on the needs of the organization.
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Salary Range - $127,000 - $160,000
Seniority level Mid-Senior level
Employment type Full-time
Job function Information Technology
Industries Plastics Manufacturing
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Cathx Site Quality Lead
role at
Zeus
Responsibilities
Ensure the effectiveness and continuous improvement of the manufacturing site to ensure customer satisfaction and achieve the quality policy objectives.
Provide daily oversight to the Quality staff at the manufacturing site with the exception of the Design assurance engineers.
Ensure compliance with 21CFR820, ISO 13485, and EU MDR 2017/745 (the requirements) as applicable to CathX at the manufacturing site.
Oversee the following activities at the site for on-time completion and compliance with requirements:
Inspection, measuring and testing
Nonconforming materials
Complaints and RMA
Corrective and preventive action
Gemba walks and LPA
Equipment and process validation
Facility maintenance
Environmental monitoring and testing
Serve as the person most responsible for quality at the manufacturing facility, in the capacity of Deputy Management Representative when the Director of Quality is not present.
Support, compile, participate in and post monthly metrics and management reviews.
Oversee the IQC/ Metrology lab and provide direction on priorities for the Quality assurance unit (IQC) at the facility. The activities of IQC include:
Receiving Inspection
First Article Inspection
Testing & metrology
Final Inspection
Nonconforming Materials
Lot history record review
Lot release preparation
Preventive maintenance
Calibration
Ensure the output of the manufacturing site IQC/ metrology lab meets Top Management KPI and quality policy objectives.
Act as the primary audit contact for external audits at the direction of the Director of Quality.
Respond to customer survey and self-assessment requests at the direction of the Director of Quality.
Review quality agreements and no-change agreements from customers at the direction of the Director of Quality.
Lead problem‑solving initiatives and improvement activities as agreed with Top Management to resolve manufacturing site or systemic issues.
Provide input to Sustaining Quality and Design Assurance engineers at the manufacturing site on best practices.
Qualifications
BS/BA, or Engineering degree with a scientific or engineering emphasis required.
Seven or more years of work experience in a regulated medical device environment.
Previous experience managing and supervising engineers, technicians and inspectors.
Six sigma Green or Black Belt preferred.
ISO 13485:2016 Lead Auditor certification preferred.
Management and leadership training or certification is desired.
Competencies
Support the values of CathX including Excellence, People, Integrity, and Creativity.
Excellent verbal and written communication skills.
Commitment to customer satisfaction and communication.
Ability to facilitate the development of direct reports.
Ability to manage tight timelines and changing priorities.
Excellent problem‑solving techniques and ability to drive to root cause.
Proficient with Minitab software and other statistical software and data analysis.
Physical Demands and Work Environment
Physical Activity – Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
Physical Requirements – Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Visual Acuity – The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. Occasionally performing visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices.
Working Conditions – The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
The performance of this position will require exposure to the manufacturing areas, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing protection.
Travel This position may require up to 10% travel to other manufacturing facilities, suppliers, and customer locations as required, dependent on the needs of the organization.
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Salary Range - $127,000 - $160,000
Seniority level Mid-Senior level
Employment type Full-time
Job function Information Technology
Industries Plastics Manufacturing
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