Senior Quality Engineer - Katalyst Healthcares & Life Sciences
Rochester, NY 14602
About the Job
Responsibilities:
- Will be responsible for managing quality related problem solving and continuous improvements opportunities.
- Lead / Support Change Control to manage business needs and continuous improvement activities.
- Provide guidance and approvals of applicable validations and change control documentation.
- Manage NC/CAPA through identification and development of corrective action plans through closure.
- Evaluate data using statistical tools.
- Provide technical support to production in defining and resolving problems.
- Ensure compliance and plant quality system elements.
- Lead and Participate in Risk Analysis activities.
- Participation in audits.
- Identifying opportunities for continuous improvement.
- Review and approval of work instructions.
- Ownership of the process control plan and its implementation.
- Other projects as required.
- Bachelor's degree in science or related field required.
- Master's degree preferred. Equivalent combinations of education, training, and relevant work experience may be considered in lieu of a Bachelor's degree.
- Minimum of 5-7 years of experience in Quality Engineering or related field within a regulated industry, preferably medical devices.
- Knowledge of ISO 13485, FDA 21CFR820 requirements in addition to system development and management in medical device industry.
- Strong statistical analysis, knowledge of sampling plans and root cause investigative skills.
- Six Sigma Black or Green Belt certification preferred.
- Computer experience with MS Office Suite and database type software.
- Demonstrated project management and leadership skills.
- Strong written, oral and interpersonal skills.
- Ability to work in team environment.
- Ability to manage varied workload and prioritize effectively.
- Exhibit attention to detail.
- Capacity for innovation and ability to work on own initiative.
Source : Katalyst Healthcares & Life Sciences