Summary of Major Responsibilities
The Manager of Quality Assurance ensures that the company operates according to its quality system to provide products that meet customer requirements and maintains compliance with applicable regulations. Is responsible for the establishment and maintenance of technical processes, procedures and work instructions, and administration in the implementation and maintenance of the quality management system processes such as ISO 9001-2015 and others as required.
VP of Operations / President
- The Manager of Quality Assurance establishes, maintains and updates quality systems policies and procedures of the company to ensure that products and processes meet applicable standards and specifications.
- Manages the company quality system and acts as the Management Representative. Reports to Senior Management on the status of the quality system as well as any noncompliance issues that surface; and ensures that corrective action is appropriately implemented. Provides Senior Management with timely communication of new regulatory agencies and new directions and publications.
- Hires, manages and reviews quality department technicians and engineers who provide guidance and support in quality improvement and the implementation of processes and controls required to meet or exceed the quality requirements.
- Develops the budgets, partnerships and capital expenditures needs for the department.
- Responsible for the completeness of documentation for product development and release.
- Identifies and appropriately elevates product/supply risks to Senior Management and develop mitigation strategies.
- Provides Quality technical expertise in the development of validation strategy for process, test method, software, and facility qualification/validation.
- Provide Quality leadership for investigations and exception management.
- Provide Quality oversight for calibration and maintenance program.
- Serve as the chair for the Material Review Board.
- Lead efforts for FMEA process and product risk assessments.
- Provide support for commissioning, FAT, and SAT for production equipment.
- Implements processes to monitor product and process performance, compliance and reliability.
- Implements, conducts and reports on process quality programs using statistical data analysis.
- Manages and maintains the company’s quality audit program and manages related corrective and preventive actions plans.
- Provides scientific and technical leadership during internal and Notified Body Inspection/Audit situations.
- Manages processes related to employee training and safety. This includes the training of personnel on company and department policies, systems and processes as well as functional and on the job training.
- BS degree in engineering or commensurate experience – preferably in mechanical or electrical engineering.
- 5 -10 years’ experience in a direct Quality Assurance role – with experience both in product development and manufacturing
- 2 or more years’ experience in a direct supervisory or leadership role with demonstrated success in motivating and effective performance management of others.
- Demonstrated experience with SAP® or other ERP business software is desirable.
- Experience with Project Management principles and practice is desirable.
- Demonstrated experience in Six Sigma techniques is desirable.
- Demonstrated expertise with Microsoft® Office programs.
- Direct experience in leading notified body audit, CAPA implementation and preparation of Management Reviews.
- Direct experience working within a ISO 9001 and/or cGMP structured environment
- Strong leadership and communication skills; strong decision making skills; ability to communicate ideas, opinions and counter arguments in a proactive and professional manner.
- Excellent oral and written communication skills, with strong attention to detail and record keeping skills.