· Provides technical expertise in Quality Planning activities, which may include: Risk Assessment support (FMEA), specification development for Raw Materials/ Components, Intermediated, Bulk, Finished product.
· Provides technical expertise in the introduction of new product through FMEA and process capability analyses as well as designing and implementing design verification/validation plan, protocols, and reports.
· Guides and directs engineering in the development of robust and efficient process and design validations with core teams, as well as perform testing methods.
· Expert in applied statistical methodologies (MSA, DOE, Sampling Plans, SPC, etc.) to support site/SBU validations and inspection requirements. Trains employees in the concepts of probability and statistics.
· including such information as the number of units to be inspected/tested, the frequency to test, test methods and yield determination.
· Leads process and product audits as well as internal Quality System audits.
· Identifies areas for improvement and leads the effort for continuous process improvement.
· Acts as liaison between departments and make independent decisions to ensure adherence to quality procedures.
· Establishes, collects, and analyzes data for metrics reporting for results of activities to identify areas of potential improvement.
· Executes verification and/or validation protocols for products and/or processes.
· Prepares reports for management and senior management as required.
· Works with all business units to improve material flow, ensure process quality, reduce work in process, and achieve required capacity/cycle time requirements to meet or exceed customer requirements.
· Leads problem/root-cause investigations for acute defect problems
· Other duties as assigned.
· Bachelor’s Degree in Engineering or another related technical discipline OR Master’s Degree in related discipline
· Certifications/Licensing: ASQ Certified Quality Engineer or Six Sigma Black Belt, required
· 2-4 years related work experience
· Prior experience in medical device industry preferred
· 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, diagram, or schedule form.
· Ability to define problems collects data, establish facts, and draw valid conclusions.
· Able to formulate an approach and plan projects.
· Ability to understand mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentage, ratios, metric measurement and proportions to practical situations.
· Lead, manage, and implement initiatives to support the QA/RA Department goals and objectives.
· Ability to Make recommendations based on review of numerical data, written reports and trends.
· Strong problem solving skills; able to come up with alternative solutions for management consideration based on data analysis.