This position develops implements and improves new and existing product quality requirements within a dynamic combination medical device / pharmaceutical R&D Technology Center.
Summary of Position with General Responsibilities:
- Provide Quality Engineering representation on Product Development Teams.
- Initiate new/revised documentation and track through approval cycles and implementation.
- Participate and/or lead cross-functional teams to develop risk assessment.
- Develop physical and functional test methods to ensure specifications are met.
- Write, review and approve design verification and validation protocols and reports.
- Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
- Conduct and /or coordinate testing outlined in protocols and test methods.
- Perform process improvement, control and monitoring on manufacturing processes.
- Provide technical direction during design transfer activities.
- Conduct complaint investigations.
- Participate and provide input to training on department/division procedures, and policies.
- Participate in project planning, budgeting, scheduling and tracking.
- Coordinate and perform internal and supplier audits.
- Develop and implement procedures to comply with corporate and industry standards.
- Understand and follow company procedures on regulatory requirements.
- Provide support to the regulatory department in writing technical submissions.
- Provide positive example and actively promote compliance to division, corporate and industry standards.
- Maintain a professional working relationship with internal and external customer and support staff.
- Prepare and present project updates and technical discussions.
Additional Desirable Qualifications Skills and Knowledge:
- Bachelors degree in Engineering or a closely related technical field.
- A minimum of 4 years experience in the medical device development or closely related industry or Masters Degree plus two years.
- Quality Engineering Certification (ASQ) or equivalent, desired.
- Working knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.
- Coronary new product development experience desired.
- Combination device/pharmaceutical and coating technology experience preferred.
- Working knowledge of; process validation requirements and application, comparative statistics, engineering cost analysis, internal and supplier audits.
- Experience supporting product, design & prototyping a plus.
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
Strong interpersonal skills
Problem solving ability
Oral and written presentation skills
Ability to lead cross functional teams
Understanding of regulatory requirements
Ability to make and present engineering decisions
Education and/or Experience:
Bachelors degree in Engineering or a closely related technical field.
A minimum of 4 years experience in the medical device development or closely related industry or Masters Degree plus two years.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
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...