At ZOLL, the business problem is to improve patient outcomes and help save lives by developing and delivering innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally.
Requirements
- Experience in an FDA regulated Class III electrical medical device manufacturing environment required
- Experienced in process development and validation for electro-mechanical assembly, test, and service
- Formal Project management experience a plus preferred
- Lean experience preferred
- Experience with database queries and reporting in SQL or Microsoft Access preferred
- Six Sigma Green Belt Certification Preferred
- Black Belt Preferred
Responsibilities
- Performs internal quality audits and effectiveness reviews (FDA’s QSR, ISO 13485, MDD, CMDR)
- Conducts supplier evaluations and audits
- Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality
- Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications
- Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses
- Prepare, submit and coordinate the process validation requirements for non-product software validations
- Participates in the FDA premarket approval process (PMA) for new and modified medical devices
Other
- BS degree required or Equivalent experience in a technical or scientific discipline required
- Ability to sit and talk or hear, stand, walk and reach with hands and arms, and lift and/or move up to 25 pounds
- Ability to work in a quiet noise level environment
- Must be able to work with cross functional departments
- Must have strong communication and collaboration skills
