Position Summary: Performs a variety of complex tasks related to Quality Assurance including, but not limited to: 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 Duties and 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.
- 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.
- Responsible to build and improve key business relationships within the organization’s cross functional departments.
- 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.
- Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented.
- 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.
- 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.
- Performs other duties as assigned by Management.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
- Requires a BS degree or equivalent experience in a technical or scientific discipline.
- Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.
- Experienced in process development and validation for electro-mechanical assembly, test, and service.
- Formal Project management experience a plus. Six Sigma Green Belt or Black Belt preferred.
- Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.
- Lean experience preferred.
- Experience with database queries and reporting in SQL or Microsoft Access preferred.
Language Skills Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
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; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.
Work Environment 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.
ZOLL is an Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.