Sr. Quality Assurance Engineer

Organization
D BASH Business Solutions LLC
Job Location
Madison, WI
Benefits

Includes solid benefits package with bonus, stock options and 401k.  Relocation assistance is available. 

Job Description

D BASH Business Solutions LLC is recruiting for a Sr. Quality Assurance Engineer with 5+ years of professional work experience.  Our client is a rapidly growing, molecular diagnostic company.  The company prides themselves on making a difference in people's lives.  They are looking for a great Sr. QA Engineer with strong relationship building skills to join their team.

Essential Duties and Responsibilities:

  • Assist the validation project lead and operations manager in project management and status updates for ongoing activities
  • Work with and provide support to Operations personnel in the completion of validation efforts for process, test method, and facility qualification/validation
  • Review and approve documents prepared by other team members and Operations
  • Provide Operations support for investigations and material release
  • Participate in FMEA process risk assessments
  • Implement processes to monitor product and process performance, compliance and reliability
  • Implement, conduct and report on process quality programs using statistical data analysis
  • Generate, prepare and issue data for assigned quality reports
  • Participate and provide Quality perspective for scale up activities including validation requirements
Requirements

Mandatory Skills

  • Proven ability to lead and work effectively with and through multi-functional teams to achieve results
  • Position requires an intermediate level of applied statistics skills used for scientific data analysis
  • Excellent interpersonal skills with the ability to collaborate closely with Operations staff at varying levels to drive compliance and operational excellence
  • Knowledge and experience working within an CFR 820, ISO 13485, ISO 9001 and/or cGMP structured environment
  • Excellent oral and written communication skills


Education and Experience

  • Bachelor’s degree in an engineering or science field with focus on Biology and/or Chemistry, or related field with the equivalent combination of education and experience
  • 5 or more years’ experience in a manufacturing operation environment
  • 3 or more years’ experience in Process Validation principles and practice


Preferred Qualifications

  • 5 or more years’ experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment
  • Experience with Project Management principles and practice
About Our Organization

D BASH Business Solutions LLC is a consulting and recruiting firm focused on the biotech industry.  Our client is a rapidly growing molecular diagnostic company in Madison, Wisconsin.

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