CMS
This senior-level position will lead a variety of complex tasks related to Quality Assurance including, but not limited to: CAPA quality system management, internal auditing quality system management, and performing trend analyses on quality data to provide early warning of potential problems, and improvement opportunities. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities including non-product software.
Essential Functions- Champions the internal audit quality process and effectiveness reviews ensuring cross functional compliance to our quality system manual, internal processes, and regulated bodies. (FDA's QSR, ISO 13485, MDD, CMDR).
- Lead the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality.
- Champions the CAPA System process ensuring cross functional compliance to our quality system manual and internal processes.
- Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance.
- Lead and improve key business relationships within the organization's cross functional departments as a quality assurance subject matter expert.
- 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.
- Leads various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
- Lead the non-product software validation process by providing project management, preparing, and coordinating the process validation requirements.
- Participates in the FDA premarket approval process (PMA) for new and modified medical devices.
- Participates in the nonconforming material/Material Review Board process.
- Championing the implementation of Lean Manufacturing processes.
- Participate in Kaizen events as a representative of the quality department.
Required/Preferred Education and Experience- Bachelor's Degree or equivalent experience in a technical or scientific discipline required.
- Minimum of 5 years of Experience in an FDA regulated medical device manufacturing environment required.
- Minimum of 5 years of experience in process development and validation for electro-mechanical assembly, test, and service required.
- Formal Project management experience preferred.
- Lean experience required.
- Lean Six Sigma Black Belt preferred
Knowledge, Skills and Abilities- Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.
Physical Demands- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.
Working Conditions- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The noise level in the work environment is usually quiet.
The annual salary for this position is:
$96,000.00 to $130,000.00
Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.
