Assist the FDA remediation team to develop, review, analyze, and validate systems used in the manufacturing and testing of Philips Automated External Defibrillators (AED) and related accessories.
Required Technical Skills:
1. Ability to assess product and system performance
2. Demonstrated abilities supporting system and process validation throughout product lifecycle
3. Project management skills with the ability to work with cross functional teams
4. Knowledge of tools and processes related to risk management
5. Experience defining and documenting validation tests, including peer review and maintaining traceability to requirements
Preferred Technical Skills:
1. Managed, generated and executed protocols for the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of GMP equipment. Performed Gap Analysis and Remediation of GMP quality systems
2. Performed system validation for 21 CFR Part 11 compliance.
Candidate must have the following:
1. Demonstrated leadership skills with ability to complete a project, lead a team, and take ownership of issues
2. Excellent problem solving skills;
3. Able to complete a project independently or with a team;
4. Able to organize and prioritize work load under pressure and time constraints;
5. Able to communicate and interface effectively with other functional groups of the company;
6. Able to effectively write procedures and reports;
7. Conscientious about quality of work;
8. Motivated to learn new things, self-starter, and interested in the AED business.
1. BS/MS Engineering or strongly-related discipline;
2. 3-5 years of experience in Manufacturing Engineering.
3. 3-5 years of experience with Process Validation, Software Validation, and Equipment Validations.
4. Very effective in a highly regulated environment;
5. Strives for excellence;
6. Ability to lead;
7. Excellent oral and written skills.