Essential Job Functions:|
1. Provide Quality Engineering representation on Product Development Teams.
2. Initiate new or revised documentation
3. Lead cross-functional teams to develop risk assessment.
4. Develop physical and functional test methods to ensure specifications are met.
5. Write, review and approve design verification and validation protocols and reports.
6. Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
7. Conduct and /or coordinate testing outlined in protocols and test methods.
8. Perform process improvement, control and monitoring on manufacturing processes.
9. Provide technical direction during design transfer activities.
10. Conduct complaint investigations.
11. Participate and provides input to training on department/division procedures, and policies.
12. Participate in project planning, budgeting, scheduling and tracking.
13. Coordinate and lead internal and supplier audits.
14. Develop and implement procedures to comply with corporate and industry standards.
15. Understand and follow company procedures on regulatory requirements.
16. Provide support to the regulatory department in writing technical submissions.
17. Provide positive example and actively promotes compliance to all standards.
18. Maintain a professional working relationship with internal and external customer and support staff.
19. Prepare and present project updates and technical discussions.
1. Ability to make and present engineering decisions2. Strong interpersonal skills3. Demonstrated Project Management skills4. Advanced statistics4.1. Understanding and application of DOE 5. Ability to lead cross functional teams6. Engineering cost analysis7. Ability to analyze and optimize manufacturing and quality systems8. Advanced product, design & prototyping skills9. Ability to create and provide training10. Software application skills11. Advanced problem solving skills12. Ability to create, review and coordinate test protocols and reports13. Ability to generate engineering proposals14. Oral and written presentation skills15. In-depth knowledge of regulatory requirements16. Ability to develop and control a budget17. Ability to manage technical personnel18. Ability to perform design review functions19.Must read, write and understand English. Must be detailed in handling information/data.
Education and/or Experience:
A minimum of a Bachelors degree in a technical field.
Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters Degree plus three years.
Quality Engineering Certification (ASQ) or equivalent.
Extensive knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.
C. R. Bard - 2 years ago
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...