Offers “Roche”

days ago Roche

Principal Quality Engineer

  • Internship
  • Branchburg, USA
  • Sales

Job description



·  Job facts

Principal Quality Engineer:

This position requires 2nd shift coverage with the potential for 3rd shift coverage, as needed.

As the Principal Quality Engineer you will work with cross-functional teams to provide quality and technical leadership to ensure RMD products meet their intended uses. In this role you will be accountable for assessment and continuous improvement of quality system processes with adherence to all regulations. Oversees the 2nd and 3rd shift Quality Assurance staff.

Essential Functions:

· 
Apply Quality Engineering expertise, problem-solving tools and basic statistical concepts, to correct and prevent product problems.

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Provide leadership in a team environment with emphasis on continuous improvement to maximize product quality with adherence to all regulations.

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Analyze processes, metrics, and quality data to identify opportunities for improvement across production processes and our quality management system.

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Act as a mentor sharing knowledge and expertise to develop other Quality professionals in areas such as root cause investigation, and data analysis, with recommendations for appropriate corrective actions based on the information/results.

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Oversees daily support of manufacturing activities, including assessing issues that arise; Material controls and disposition; Nonconformance, Validation, and Variance review and approvals.

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Provides guidance for investigations of discrepancies or failures related to manufacturing and control systems. Includes collaborating on various non-conforming situations and investigation activities assessed in Quality Analysis Reports (QARs); evaluates root cause and actions and ensures documentation is complete and accurate.

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Reviews Quality System documentation, including Production Batch Records, Variances, and Quality Analysis Reports (QARs), and appropriately dispositions affected materials. Performs disposition of manufactured lots, assuring product quality and SAP/LIMS database integrity in compliance with Quality System regulations.

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Participates in Internal and External audits, when necessary.

Qualifications:

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Education (Minimum Required): Bachelor Science Degree - Engineering

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Experience: At least 6 years of related experience or MS degree in directly related discipline + 4 years of related experience or PhD in directly related discipline + 2 years of related experience required.

· 
ASQ-Certified Quality Engineer

Skills:

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Proficiency with quality and data analysis tools

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Analyzing data and information based on statistical techniques

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Expert knowledge and application of engineering principles and concepts

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Problem solving and in-depth analysis skills

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Superior analytical, interpersonal, communication, organizational and leadership skills.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com .

·  Who we are

At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.