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PROJECT (CLINICAL) MANAGER 2
Sunnyvale, CA US
Posted: 02/17/2023
2023-02-17
2023-04-21
Job Number: 19049031
Job Description
Title: Sr. Continuous Improvement Quality Eng.
Location: Sunnyvale, CA
Duration: 9+ Months Contract
Key Responsibilities:
Reporting to the Sr. Manager, Continuous Improvement Quality Engineering, the Sr. Continuous Improvement Engineer is 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 ISI standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
S/he will lead CAPAs and collaborate with subject matter experts on various activities in addition to supporting other improvement initiatives.
S/he will evolve existing processes/systems to ensure timely escalation identification of product quality & 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.
S/he will lead internal audits, as necessary.
Skills:
Minimum Bachelor’ s Degree in engineering or a related field
• 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.
• Experience gathering/processing internal and external requirements.
• Business Acumen - has demonstrated 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.
• The ability to 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.
• Ability to travel up to 10% of the time.
Location: Sunnyvale, CA
Duration: 9+ Months Contract
Key Responsibilities:
Reporting to the Sr. Manager, Continuous Improvement Quality Engineering, the Sr. Continuous Improvement Engineer is 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 ISI standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
S/he will lead CAPAs and collaborate with subject matter experts on various activities in addition to supporting other improvement initiatives.
S/he will evolve existing processes/systems to ensure timely escalation identification of product quality & 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.
S/he will lead internal audits, as necessary.
Skills:
Minimum Bachelor’ s Degree in engineering or a related field
• 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.
• Experience gathering/processing internal and external requirements.
• Business Acumen - has demonstrated 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.
• The ability to 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.
• Ability to travel up to 10% of the time.