- Responsible for Quality Engineering and strategic business related programs.
- Works collaboratively with other Operations Product Quality team to facilitate Engineering and Operations Management maximize efficiencies, achieve annual goals.
- Leads key Lean Quality projects such as reduction in rework, reduction in quality notifications, etc., and improves product quality processes attending Kaizen events, process mapping, 5s, or other lean tools.
- Responsible for creating and supporting a quality culture by driving activities across the organization to manage continuous process/quality improvement programs that strongly align with standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
- Lead CAPAs and collaborate with subject matter experts on various activities in addition to supporting other improvement initiatives.
- Evolve existing processes/systems to ensure timely escalation identification of product quality and compliance issues within a closed loop quality management system.
- Work to collect and analyze data, drive rigorous root cause analyses and facilitate cross-functional discussions to ensure we are seeing 'all the way around' issues for complete resolution.
- Lead internal audits as necessary.
- Minimum Bachelor’s Degree in engineering or a related field; OR
- Advanced degree (Master’s in Engineering or a related field) preferred
- Minimum 8+ years of progressive hands-on experience; or equivalent combination of education and experience.
- Strong interpersonal and communication skills
- Ability to scale and deliver presentations based on audience background.
- Knowledge of Quality Systems Regulations (21 CFR 820), ISO 13485 and ISO 14971 preferred.
- Knowledge and hand on experience with Process improvement tools and methodologies (Lean, Six Sigma).
- Green or Black Belt Certification in Lean or Six Sigma is preferred.
- ASQ certification (CQE) is a plus.
- Is familiar with the Gemba process and product quality improvement on the production floor.
- Experience gathering/processing internal and external requirements.
- Business Acumen - has business knowledge and ability to display the linkage between projects and desired business results.
- Proven ability to drive creative problem solving related to product and process issues.
- Collaborate effectively with product and/or process subject matter experts in a cross-functional team environment is required.
- Technical aptitude is required to collect and analyze data for determining an improvement strategy.
- Ability to navigate multiple projects with changing priorities. Ability to execute to project timelines. Project Management experience and certification preferred.
- Strong analytical, problem-solving and RCA skills.
- Proven track record of managing and successfully closing CAPAs on time and with objective effectivity.
Source : Synectics