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Sr. Quality Assurance Engineer
Portage, MI 49002 US | Work from home flexibility TELECOMMUTE US
Job Description
Position Description
This Quality Engineer role is in support of recent a acquisition, where the QMS of an acquired company must be merged with the existing QMS. Experience in process flow mapping and documentation desire.
MAJOR DUTIES/RESPONSIBILITIES:
- Gather and analyze data to identify opportunities for quality improvements.
- Drive failure investigation to root cause when applicable using known engineering problem solving techniques.
- Lead an/or support NC/CAPA process and NC/CAPA investigations stemming from Post market.
- Resolve potential Medical device reporting (MDR) investigations.
- Lead product failure investigations to completion.
- Champion product failure investigations to closure.
- Document each investigation thoroughly in accordance with the internal procedures within complaint handling systems(s).
- Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required.
- Provide service report and complaint trending.
REQUIREMENTS
- Bachelor's Degree in applicable engineering discipline preferred: Biomedical, Process or Mechanical Engineering
- Minimum of 3-5 years in a quality role for a medical device company: this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment.
- Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable
- Excellent verbal, written and interpersonal communication skills
- Excellent problem solving and analytical skills
- Excellent technical writing skills
- High level of attention to detail and organization
- Prior related experience in a regulated environment highly desired.
- Prior related experience investigating, troubleshooting and root causing highly preferred.
- Participate in internal and external audits, as required.
- Trackwise experience highly desired.
- Ability to read and interpret engineering drawings and other technical specifications preferred
- Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics)
