Rock Hill, South Carolina | October 17, 2019
Essential Duties and Responsibilities:
- Promotes quality achievement and performance improvement throughout the organization.
- Organizes and manages quality assurance function in close cooperation with the Customers and with the Management Team (Member of Management Team).
- Develops and maintains the Quality Management System.
- Functions as the site Management Representative
- Provides leadership, mentoring and supervision of the Quality Assurance department
- Provides technical and process direction to department employees.
- Evaluates employees through performance reviews, ongoing coaching and feedback methods.
- Edit, approve, and submit employee timecards weekly.
- Analyzes and resolves, or assists associates in solving problems.
- Coordinates and manages Corrective Action and Continuous Improvement projects across multi-functional teams (including lean and scrap reduction projects)
- Analyzes failures and implements Corrective and Preventive Action in response to Customer complaints.
- Creates and maintains company quality documentation, such as quality procedures, work instructions, etc.
- Effectively interacts with Production and Engineering teams to maintain product supply and help introduce new products.
- Establishes quality requirements from external suppliers.
- Ensures compliance with national and international standards and legislation.
- Manages all internal quality audit activities.
- Liaises with Customers’ auditors and ensures the successful execution of Corrective Action and compliance with Customers’ specifications.
- Monitors performance by gathering relevant data and producing statistical reports.
- Identifies relevant quality-related training needs and facilitates applicable training
- Collates and analyzes performance data and charts against defined parameters.
- Writes technical and management systems reports.
- Manages and maintains the quality inspection and product release programs for in-process materials and components, processes and finished goods.
- Formulates and manages the development and implementation of goals, objectives, policies, procedures, and systems pertaining to QA/QC.
- Sets QA compliance objectives and ensures that targets are achieved.
- Maintains awareness of the business context and company profitability, including budgetary control issues.
Education and/or Experience:
- Four (4) Year College Degree required, a degree in engineering science preferred
- Minimum 5 years experience in Quality Assurance in a manufacturing environment (rubber components and/or medical manufacturing preferred)
- Minimum 3 years of experience in a leadership/supervisory role.
- CQE or CQM
- Six Sigma Black Belt
- Sound knowledge of GD&T, FMEA, DOE, GR&R activities
- Sound knowledge and practical experience of ISO 13485 quality systems
- Sound knowledge of FDA Quality System Requirements