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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:
- ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow/Green/Black Belts, and/or other similar certifications.
Skills & Competencies:
- 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
Physical Requirements:
- 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.
RESPONSIBILITIES:
- 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
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