The Quality Manager is responsible for the oversight and maintenance of the ISO quality management systems, primary contact for all external quality issues and Regulatory affairs, and responsible for distribution of all Quality reports including Statistical Process Control analysis.
Essential Responsibilities:
Serves as ISO Administrator, maintaining the ISO management quality systems.
Serves as Lead Auditor, managing the internal audit program and overseeing internal audits to verify company compliance with the quality system.
Reports non-compliance with the quality system to the involved parties and makes recommendations regarding plan changes if necessary.
Manages corrective/preventative action requests.
Conducts data analysis and certifies shipments with Certificates of Analysis.
Participates in product specification creation and adjustments.
Prepares statistical quality data for monitoring process control.
Prepares monthly quality objectives reports.
Conducts annual post-market surveillance to determine if any Medical Device Reports have been filed for our medical devices or similar devices.
Conducts quarterly and annual quality meetings with the management team.
The primary liaison between external certifying bodies and/or agencies and the company.
Direct contact for any regulatory affairs issues.
The official FDA and ISO Management Representative for the Quality System.
Supportive of quality auditors.
Maintains particle and hexane extraction testing process and lab.
The primary contact for the calibration service and ensures that all equipment calibrations are kept up to date.
Perform other key activities as required.
General:
Participate in all production planning meetings and/or reviews with sales associates.
Regular and predictable attendance is required between the assigned start and end times of work.
Ability to work independently within parameters set by management.
Attend training programs to develop relevant knowledge, techniques, and skills.
Participate and/or oversee special projects beyond daily operations and other assignments to support/fulfill corporate strategies.
Perform other key activities as required.
Qualifications:
Relentless determination and courage to make things happen; strong execution skills; results oriented.
Excellent communication skills and ability to interact across all levels of the organization, while accomplishing organizational goals.
Capability to establish course of action for self and/or others to accomplish goals.
Ability to respond quickly to changing demands, processes, and updated information while managing multiple projects and tasks with clear prioritization.
Demonstrated understanding of quality processes and continuous improvement, such as Lean and/or Six Sigma.
Strong analytical problem-solving aptitude with ability to organize work efficiently, manage multiple projects and deadlines simultaneously with strong attention to detail.
Willing to travel (including overnight) as needed.
While the regular working cycle of this position is usually 5 days (Monday-Friday), this job may include working weekends (Saturday and Sunday). Working hours may vary as specified by management. Incumbent must be able to work overtime as directed by management.
Working knowledge of PC operations & software including Word, Excel, PowerPoint, and Outlook.
Dependable, Creative, and Innovative.
Relationships:
This position will report to the President and/or General Manager. The position will also interact with the Operations Manager, Sales staff, Chief Financial Officer, Planning & Purchasing Manager, Office Manager, customer support individuals, and production management/staff.
