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.
Must be able to travel to visit suppliers and customers.
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 use hands to finger, handle, or feel and reach with hands and arms. The employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
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.
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and vibration. The employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate.
Additional Salary Information: We offer a competitive total compensation package to employees including PTO, Medical, Dental, Vision, 401(k), ect.
About Roechling Medical Lancaster, LLC
Röchling is a family-owned, medium-sized corporate group that specializes in processing engineering plastics. We are one of the global leaders in this field. The capital goods sector, automotive industry, medical and pharmaceutical technology providers – our innovative products are trusted by a wide variety of customers. And yet, our aim is always the same: We see what our customers need and provide them with the solutions they seek. Röchling stands for competence in plastics.