Plans, conducts, or leads activities and projects concerned with quality systems, process control, quality assurance, risk analysis, process improvement, and validation of manufacturing and business processes in a regulated environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.
Provide support in the areas of supplier qualification, metrology, measurement system analysis, process capability, quality planning, and risk analysis to Engineering and Manufacturing personnel during process and product development activities.
Work with Engineering and Project Management during change activities, utilizing appropriate Quality tools to ensure changes are thoroughly evaluated for elements of risk, validation status, and effects on customer requirements. Ensures that changes are controlled, and include a clear implementation plan.
Using analysis of quality system data, process data, and part data, recommends, conducts, or leads improvement activities in order to ensure that critical processes are appropriately defined, documented and controlled in order to provide a high degree of assurance that process outputs will meet requirements.
Perform training as required on Quality Concepts and Tools.
Perform Supplier Audits at Supplier’s place of business.
Assist in external audits by regulatory agencies, certifying bodies or customers.
Lead problem solving teams and/or be a resource for problem resolution. This includes leading or assisting in Root Cause analysis and Corrective Action identification and implementation. Able to lead and participate in concurrent teams.
Develop, Document, and Implement Inspection methods and sampling plans including inspection and testing SOPs and data collection forms.
Analyze trends, prepare reports or presentations for management review and improvement activities
Manage Internal Audit Process including scheduling of audits and coordinating the reporting and closure of any required corrective actions.
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
Bachelor's degree (B. A. or B.S.) from four-year College or university; plus 5 years related experience and/or training in a regulated industry preferably medical or pharmaceutical, or equivalent combination of education and experience.
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.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply statistical mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
To perform this job successfully, an individual should have knowledge of, Datamyte Database software; Statistical analysis software; Explorer and Outlook Internet software; Visual Manufacturing software; Microsoft Project project management software; Microsoft Excel Spreadsheet software and Microsoft Word word processing software.
CERTIFICATES, LICENSES, REGISTRATIONS
ASQ certification in Quality Management, Quality Engineering, and/or Quality or Biomedical Auditing preferred., Valid Driver's License.
OTHER SKILLS AND ABILITIES
Experience in ISO 13485 certified industry, Lead auditor training and Experience with performing audits, working knowledge of 21CFR820, CMDR, and EU MDD all desirable.
Additional Salary Information: Company offers a very generous benefits package, as well as above average starting salary