Abbott is seeking a Section Manager, QA Engineering to supervise engineers and technicians, contribute to new product design and development, and ensure compliance with medical device regulations.
Requirements
- Bachelors Degree in Engineering or related field
- 7+ yrs of experience in Quality Assurance or Engineering
- Minimum 5 years of experience in the Medical Device Manufacturing or Pharma industry
- Minimum 3 years direct experience in Design Control
- Working knowledge applicable regulations and standards such as FDA, QSR, ISO 13485, ISO 14197, MDD and IVDD
- Strong analytical skills, problem solving techniques and statistical application experience
- Knowledge in the areas of Medical Device and Development, Design Controls, V&V activities, mfg practices, statistical techniques
Responsibilities
- Supervise engineers and technicians
- Contribute individually as Technical Design QA representative on new product design and on-market development / change teams
- Build and maintain successful cross functional relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs
- Provide support to Clinical Material Release, Quality Control, and Calibration programs
- Manage Design Control metrics, equipment calibration oversight
- Directly supervise a team of Quality engineers and analysts
- Lead new product development teams in addressing technical quality issues
Other
- Bachelors Degree in Engineering or related field. Mechanical or Biomedical Engineering Degree preferred. MBA strongly desired
- Minimum 5 yrs of experience in functional management – experience managing direct reports
- Must be able to lead new product development teams in addressing the technical quality issues arising for complex new diabetes care related products
- Demonstrated written, oral and interpersonal skills
- Lean Six Sigma training or certification preferred
