Manager, Quality Engineering (Cincinnati)
Enable Injections IncCincinnati, OH, USjob_description.job_card.variable_hours_ago
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job_description.job_card.job_descriptionASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow / Green / Black Belts, and / or other similar certifications. Experience in quality management systems is essential Knowledge of FDA regulation 21CFR820 required, knowledge of 21CFR 211 preferred Knowledge of international standards and regulations (i.e., MDR, ISO13485, ISO14971, etc.) Experience managing staff including administration and professional development Ability to develop personnel through mentoring and coaching, both formally and informally, and most importantly by example Proficiency in using problem solving methods, root cause analysis and use of statistical tools to resolve problems Experience with Gage R&R studies and understanding of statistical principles Experience managing complex or high-level projects Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality Strong ability to facilitate discussions and negotiate mutually beneficial solutions when necessary Demonstrated strong leadership skills and interpersonal skills Excellent interpersonal, organizational and communication skills Strong writing and editorial skills with attention to detail Prior participation in regulatory inspections and audits Working knowledge of engineering drawing interpretation Expert knowledge in systematized approach to problem solving and process / product FMEA Strong computer skills in Word, Excel and Outlook Experience in developing and conducting presentations with Power Point Must be able to remain in a stationary position for extended periods of time Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. Provide leadership to Product Development teams by ensuring Design Assurance through the Design Control processes Provide leadership to QE personnel and ensure they are properly trained and equipped Ensure Design Control methodology is followed in new product development Develop and maintain Design Control Program and Risk Management quality programs Develop Design History Files in accordance with company and 21 CFR 820 and ISO 13485 requirements Ensure all products meet contractual requirements defined by customer purchase orders. Responsible for QE staff to ensure product conformance at component, subassembly & final assembly Establish departmental metrics and goals in support of organizational strategic goals. Create performance metrics for QE functions that measure performance, and highlight improvement effort results Review existing procedures to ensure the most efficient methods are employed, lead changes where needed, and revise procedures accordingly Author procedures that accurately reflect processes and are compliant to applicable standards Communicate expectations with personnel by establishing individual annual performance goals, with follow-up, and provide the leadership to ensure their success Develop and implement personnel training plans to improve competencies as required Foster and promote open communications with supported departments such as Engineering and Operations Establish cross-training with QEs to support surge operations
Manager, Quality Engineering
Qualifications
Required :
- Bachelor's Degree in Engineering discipline
- A minimum of 8 years of device design and development experience, working in a highly regulated environment, quality, manufacturing, or engineering
- At least 5 years in Quality Engineering
- Master's Degree is considered as an additional 2 years of experience
- Minimum of 1 year of experience in managing employees or teams
Preferred :
Skills & Competencies :
Physical Requirements :
Responsibilities
Nearest Major Market : Cincinnati
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Quality Engineering Manager • Cincinnati, OH, US