Specialist Quality Assurance

The Opportunity

This is an Onsite Required Position.

Main Responsibilities

• Provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions.
• Affords assistance to engineers in developing methods and procedures to control or improve manufacturing processes.
• Ensures compliance with applicable Corporate and Divisional Policies and procedures.
• Performs returned goods analysis and enters data for post-market surveillance activities.
• Affords assistance to engineering in providing manufacturing support by learning to analyze data and identify manufacturing issues and trends.
• Might also train operators on basic processes and engineering changes.
• Affords assistance in identifying Manufacturing issues by working with Engineering to determine root cause and implement corrective and preventative action.
• Learns process to disposition returned material by utilizing quality tools and by developing knowledge of manufacturing practices and procedures.
• Affords assistance to Engineering in supporting process development during new product introduction by providing input to traceability and inspection requirements, providing input for statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications.
• Affords assistance to Engineering with qualification and validation studies & reports by collecting, compiling, measuring, organizing and recording data, and by writing procedures.

Required Education

• A High School Diploma or GED, or an equivalent combination of education and work experience.

Required Experience

• 2+ years related work experience.
• Knowledge of applicable regulations and standards affecting the manufacture of Medical Devices (i.e., cGMPs and CFRs).
• Industry / supervisory experience and direct exposure to Operations desired.
• Applies broad knowledge of general technical concepts and practices and a general understanding of product or systems fundamentals.
• Utilizes increased knowledge of numerical and statistical data and computer software programs to resolve non-routine/moderately complex problems.

Qualifications

• Works in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Performs non-routine to moderately complex technical assignments using standard methods and sequences.
• Performs set-up, testing, repair, inspection, and/or maintenance of all area-specific equipment, materials, systems, and/or product.
• Makes adjustments, modifications, and replacements as directed.
• Assignments require broad judgment in troubleshooting proven processes as well as the ability to suggest alternatives.