Superior Jobs


Project (clinical) manager

  • ID: 503558
  • Posted: 3/9/2022
  • Location: Sunnyvale, CA
  • Category: Admin - Administrative
  • Job Type: Temporary
  • Duration: 9 - 12 Months


Acara solutions is looking for PROJECT (CLINICAL) MANAGER  for our client located in Sunnyvale,CA

  • QE will be 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
  • Improves product quality processes attending Kaizen events, process mapping, 5s, or other lean tools.
  • 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 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.

Pay and Benefits:

  • The Salary for this position is between $ 60.00 and $63.00  per hour (Max Pay rate).
Job Requirements

Required Skills / Qualifications:
  • Bachelor's Degree
  • Minimum of 8 years of experience in Project Management
  • Minimum of 8 years of experience in Process improvement tools and methodologies (Lean, Six Sigma).
  • Minimum of 8 years of experience in gathering/processing internal and external requirements.
Preferred Skills / Qualifications:
  • Master's Degree
  • 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 with Process improvement tools and methodologies (Lean, Six Sigma).
  • Green or Black Belt Certification in Lean or Six Sigma is preferred.
  • ASQ certification (CQE)
  • Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and business results.
  • Proven ability to drive creative problem solving related to product and process issues.
  • The ability to collaborate effectively with product or process subject matter experts in a cross-functional team environment
  • Technical aptitude is needed to collect and analyze data for determining an improvement strategy.
  • Ability to navigate multiple projects with changing priorities.
  • Ability to execute to project timelines.
  •  Analytical, problem-solving and RCA skills.
  • Proven track record of managing and successfully closing CAPAs on time and with objective effectivity.
  • Is familiar with the Gemba process and product quality improvement on the production floor.

Additional information:

  • Upon offer of employment, the individual will be subject to a background check and a drug screen. 
  • Ability to travel up to 10% of the time.
  • Project Management certification.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.

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