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