Quality Systems Supervisor

Position Summary

Principal Responsibilities

•    Ensure the effective implementation of the Quality Management System.
•    Establish processes for metric management and reporting.
•    Maintains the table of local and regional indicators and quality data.
•    Maintains the programming of external audits, reports their results, and ensures timely follow-up of the findings.
•    Coordinate the Internal and External audits.
•    Supervise the Document Control Team ensuring compliance with global and regulatory requirements.
•    Supervise the Calibration Technician ensuring equipment use and manufacturing controls are properly calibrated per national and international standards.
•    Supervise Training Associate ensuring training, procedures, SOPs, and policies are up-to-date.
•    Ensure timely implementation of corporate policies, procedures, and work instructions.
•    Coordinate and advise the projects of Corrective and Preventive Actions
•    Lead special quality projects related to quality costs.
•    Compile, register, and analyze data to generate reports related to the area under his responsibility.
•    Provides support to the activities of Quality Management Systems in accordance with the direction of senior management.

Education / Experience Requirements

•    Bachelor's Degree preferred. Prefer focus on engineering, life science, or related disciplines.
•    Minimum of 3 years experience in Quality Assurance experience required.
•    Experience in a manufacturing environment, with preference in a regulated or medical industry.

Specialized Skills / Other Requirements

•    Knowledge of QSR, CFR, cGMP, and ISO regulations (required)
•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint are required.
•    Experience with Minitab and SAP, ERP is preferred.
•    Working knowledge and/or experience with SAP and AGILE is strongly preferred.
•    Statistical Techniques preferred (DOE, SPC, and Gage R&R).
•    Problem-solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc.)
•    Good listening, verbal, and written communication skills
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    Ability to prioritize and adapt to shifting priorities.
•    Ability to work independently with limited supervision.
•    Design Control and Risk Management experience preferred.