Quality Manager - OEM

This position is responsible for developing and maintaining a Quality Management System (QMS) capable of supporting all general certifications required for Class I Medical Devices, compliance initiatives as governed by ISO 13485 & FDA 21CFR 820 and regional certifications supporting global distribution of OEM products.

The Quality Manager - OEM reports directly to the Vice-President. This position reports indirectly to the OEM Value Stream Manager. Reporting directly to this position are the OEM Product Quality Auditors.

As Management Representative, the Quality Manager schedules and facilitates annual Management Review. They are responsible for communication & review of all activities associated with FDA compliance & annual certifications to ensure awareness of applicable regulatory and quality management requirements throughout organization. (std. ISO 13485:2016)

The Quality Manager works with Wahl personnel, the customer, and certified regulatory bodies to ensure compliance to ISO 60601, EN14971, EN62368 & EU MDR requirements. Ensures processes required of the Quality Management System (QMS) are properly documented. They supervise the Manufacturing Operations Quality Audit Body, typically consisting of 3-5 individuals.

This individual will have an astute understanding of CAPA Systems and responsibility to administrate and track all corrective & preventative actions as well as NCP activities in QMS Software System (QT9). They will also review and interpret 3rd Party Registration Body & Internal Audit results; identify nonconformities and issue CAR / PAR accordingly.

They will play an important role in Supply Chain Integrity ensuring suppliers are properly vetted, approved prior to use, and continuously monitored for conformance to all applicable regulatory requirements. This includes maintenance of supplier ISO certifications and performance; OTD (On-Time Delivery) / Nonconformance History / CAPA Activities & Responsiveness. Additionally, they will provide overarching support of continuous improvement activities as related to voice of the customer.

In performing the functions of this position, the Quality Manager - OEM is in daily contact with members of OEM value stream to provide support for all continuous improvement initiatives. The performance of this position is measured by overall system & product integrity as well as evidence of a strong continuous improvement culture and permanent resolution of problems through effective corrective and preventative action activities.

PRINCIPAL ACCOUNTABILITIES:

• All general certifications required for Class I Medical Devices under ISO 13485.
• All regional certifications supporting distribution channels for OEM products.
• Periodic reporting to top management on effectiveness of the Quality Management System. (std. ISO 13485:2016)
• Administrate Internal Audit Program and schedule that meets 3rd party regulatory requirements.
• Schedule and facilitate annual 3rd Party Registration activities.
• Ensure document control system remains compliant to applicable standards.
• Oversee revision control, approval, release, distribution, and training of all QMS documentation.
• Ensure QMS Software System (QT9) is maintained; job descriptions correlate with personnel and associated training records.
• Administration and maintenance of training matrix allowing the assignment of personnel to only those responsibilities to which they have been trained to conduct.

• Responsible for the identification, isolation, and appropriate disposition of defective materials & products.
• Ensure risk assessments related to NCP's meet guidelines for effectiveness and adhere to all requirements associated with 14971:2019.
• Responsible for the procurement and maintenance of measurement devices used to determine product conformance.
• Management of customer complaint data, field returns, diagnosis, reporting and associated data base.
• Supervises day-to-day operation of Quality personnel assigned to OEM.
• Performs other duties as assigned by acting manager.

Current Openings for Quality Manager OEM Jobs at Wahl Clipper Corporation