Job Description:
We are seeking a skilled Quality Operations Engineering Manager to support our operations as we continue to expand. This is an onsite role.
Your role will be to manage and provide direct and indirect supervision to skilled and intermediate-level professional employees performing diverse roles within the quality function or unit.
You will be required to provide direction, coordination, and the tools needed to achieve and maintain the site Quality Management System and enable the achievement of quality objectives.
* Main Responsibilities:
* Supports generation of performance metrics for products and processes of moderate complexity.
* Drives the team to achieve Quality Goals set by management following industry standards such as ISO, IPC, AS, and TL.
* Leads Quality Improvement Programs (QIP) in support of customer requirements and expectations that are considered medium in scale and moderately complex.
About You
To be successful in this role, you will need:
1. A minimum of 7-10 years' experience in a Quality role.
2. 2 – 5+ years regulatory affairs experience or related experience in medical device industry and/or Pharmaceuticals is required.
3. Working knowledge of FDA and international regulations.
4. Experience working directly with FDA, notified bodies and/or international health authorities is desired.
5. Degree qualifications (NQF L8 or L9) minimum in a related field or consideration of an equivalent combination of education and experience.
6. In-depth knowledge of quality metrics, ISO standards and processes.
7. Knowledge of Lean and Six Sigma Manufacturing processes and controls including: Statistical Process Control (SPC), 5S and Value Stream Mapping (VSM).
8. Strong knowledge of Quality Management tools including: Failure Mode and Effect Analysis (FMEA) and development of Quality Control Plans.
9. Ability to coordinate a wide variety of resources to meet production quality and quantity metrics.
10. Ability to effectively communicate with a wide variety of internal and external customers.
11. Ability to effectively lead, manage, train and motivate a diverse group of employees to achieve high production levels within tight time deadlines and in a highly dynamic manufacturing environment.
12. Ability to use some or all of the following PC applications: Google Applications, Word, Excel, and PowerPoint.
13. Excellent knowledge of the manufacturing processes.