| Urgent Requirement || QA Manager, Quality Operations || Elkton, Maryland Onsite at Maryland, New York, USA |
| Email: [email protected] |
| From: jatin parashar, Vyze Inc [email protected] Reply to: [email protected] Hi, I hope you are doing well, Job Description Title: Manager, Quality Operations Location: Elkton, Maryland Onsite Duration: 9 months Visa: NO/H1B/CPT MOI: Skype Job Details: 1. Establish and promote a work environment that supports compliance with the TMC Quality System and Terumos policies 2. Support the development of efficient and effective methods for meeting Quality System requirements. 3. Prepare, communicate, and evaluate team goals and objectives for continual improvement of the quality system. Ensure linkage to Strategic Quality Plan. 4. Manage a team of Quality Engineers in driving robust problem solving, NC reduction and continual improvement efforts. Drive values stream optimization through the application of proven methodologies such as Six Sigma, LEAN, Kaizen events etc. 5. Promote production line value stream characterization and optimization efforts. Ensure process control plans (SPC, sampling, inspection methods) are appropriate and effective. 6. Ensure operations related CAPA activities are managed in a complete and timely manner. 7. Effectively partner with Operations Managers and Supervisors to develop and implement strategies which promote the Terumo Quality Culture throughout operations. 8. Ensure transfers to manufacturing are data driven and robustly executed. 9. Partner with internal support functions (i.e. laboratory operations, calibration & metrology, supplier control, distribution etc.) to achieve functional excellence. 10. Manage Quality Assurance inspection staff and processes related to incoming inspection and release of finished goods. 11. Manage Quality Control staff activities. Background Experience Bachelor degree in science/math required Minimum of 10 years Quality Assurance experience Minimum 5 years of management experience Six Sigma/LEAN experience, expertise preferred Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook Knowledge, Skills and Abilities (KSAs) Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDR etc., LEAN Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred Ability to identify the strategic direction of the quality assurance system required Ability to analyze and interpret all regulatory and quality guidelines as needed Demonstrate a strong understanding and working knowledge of the Quality Sciences (Acceptance Sampling, SPC, continual improvement, Six Sigma, LEAN, Design of Experiments, COQ, Cause & Effect analysis etc.) Demonstrate a strong "business partner" approach and attitude providing creative and innovative solutions that meet quality standards Manager notes They need to understand the following flow Need to know how to develop PFMEA, from there control plan, from there sampling plan, from there decide what needs to be validated in terms of TMV and process validation What is a control plan Control plan - What kind of inspections each product needs to go through step by step from raw material all the way to sterilization or final release - and details every process step along with the inspection - what is the inspection method used, what is the acceptance criteria, what happens if the acceptance criteria fails ie, what we test, at what frequency, and what samples, and what are the critical dimensions we want to control - step by step list of items that we want to check for at each process step - the specification, the range, etc. They have developed sampling plans They have Led CAPAs They have led validations (not just handled the paperwork, or approved the reports) theyve hands-on executed validation TMV (test method validation as well as IQ/OQ/PQ) They have managed others They definitely need high volume manufacturing They definitely need Engineering Degree Jatin Parashar. Technical Recruiter E: [email protected] Keywords: golang North Carolina |
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| Fri Aug 11 19:10:00 UTC 2023 |