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Quality Engineer I, Controls Quality Assurance

Company: Thermo Fisher Scientific
Location: fremont
Posted on: May 3, 2021

Job Description:

How will you make an impact?

The Quality Engineer (QE) will monitor and improve the quality of our operational processes and outputs. The Quality Engineer's responsibilities include designing quality standards, inspecting materials, equipment, processes, and products, establishing quality standards by identifying shortfalls, developing corrective measures, and implementing quality controls.

What will you do?

Key Responsibilities:

  • Developing and implementing quality standards and procedure controls

  • Monitoring and analyzing quality performance

  • Develop quality metrics for management review and daily Tier boards

  • Inspecting materials, equipment, processes, and products to ensure quality specifications are met

  • Collaborating with operations to develop and implement controls and improvements

  • Ensuring that workflows, processes, and products comply with the ISO 13485 and FDA regulations

  • Investigating and troubleshooting product or production issues

  • Developing corrective actions, solutions, and improvements

  • Support complaint investigations and closure

  • Support non-conformances and CAPA process

  • Initiate process and procedure change control through DCOs/PCOs

  • Perform risk assessments

  • Participate in new product or design change projects to ensure design controls are followed

  • Embrace PPI and continuous improvement

  • Other duties as assigned, for example supporting the internal and external audit program

Working Conditions:

  • Ability to work in a fast-paced environment

  • Must be flexible to work varying schedule, if required

  • Must be able to multi-task

  • Can lift at least 20lbs

Safety:

  • Complying with all company safety regulations and procedures

  • Serving as an effective safety steward by ensuring accurate reporting of near misses and attending safety training

  • Operating a safe work environment through continuous safety awareness and full compliance to all EHS programs and activities.

  • Maintain compliance to PPE requirements

How will you get here?

  • A Bachelor's degree in Engineering or equivalent

  • Minimum of 1-2 years of experience in Quality

Knowledge, Skills, Abilities

  • Demonstrates strong communication skills

  • Consistently delivers positive and productive results

  • Interacts well with all employees utilizing strong interpersonal skills

  • Follows written and verbal instructions accurately and efficiently

  • Ability to consistently meet deadlines

  • Embrace PPI and continuous improvement

  • Understands Quality System Requirement (QSR) and ISO 13485

  • Strong customer service orientation

  • Good written and oral communication

  • Ability to handle multiple priorities

  • Must have excellent track record of working cross functionally and ability to think strategically

Experience Preferred:

  • Experience with MS Office, pivot tables and databases

  • Experience with Continuous Improvement and 5S theories and principles

  • Knowledge of ISO 14971, Medical Devices - application of Risk Management

  • Knowledge in biological materials and chemicals is a plus

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Keywords: Thermo Fisher Scientific, Fremont , Quality Engineer I, Controls Quality Assurance, Other , fremont, California

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