Quality Engineer

Ivoclar Vivadent Ag•Franklin Township, NJ

14d•$80,000 - $105,000

About The Position

Maintain policies and procedures to ensure regulatory compliance by following FDA QSR, ISO, and any other regulatory requirements as applicable. Responsible for non-conforming material reporting and analysis system. Responsible for participating in resolution of quality issues within the manufacturing plant and partnering with other manufacturing and engineering departments to implement quality improvement projects as assigned. Generates reports and provides analysis and identifies trends. Provides training to individuals in the system as defined. Responsible for the CAPA system. Coordinates cross functional teams to provide structured root cause analysis and develop action plans. Facilitates timely implementation of actions. Support process improvement projects through implementation, including training on new processes and measurement systems. Follow up to ensure effectiveness of actions. Responsible for customer complaint systems including coordination of investigations and review of root cause analysis. Gather, analyze and distribute data from various quality system elements as assigned. Provide trending and analysis of quality related metrics. Apply mathematical/statistical concepts to understand and interpret data for trend analysis. Create or update procedures. Maintain procedures relevant to scope of job description. Participate and lead internal audits as a member of the facility internal audit team. Support and, if required, participate in third party audits. Define and implement continuous improvement processes within Quality Management Systems. Perform other related duties and assignments as required.

Requirements

Bachelor's degree in the sciences, engineering, or related field
Experience in a FDA QSR and/or ISO regulated industry
Familiarity with interpreting regulations and quality systems
Strong communication and interpersonal skills, both oral and written
Proven ability to lead cross-functional teams in discussions as it relates to root cause and action development
Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
Ability to effectively manage time to meet assigned deadlines and prioritize multiple work assignments
Ability to plan and implement resolutions to technical problems
Ability to travel both domestic and internationally
Ability to work independently with minimal instruction and supervision
Ability to deal and adapt with frequent change, delays, or unexpected events
Computer literate in Microsoft Office and Excel
Competent in utilizing statistical analysis tools
Ability to sit or stand for up to 8 hours per day, view computer monitor and move about between departments and buildings to effectively fulfill the essential functions of the job
Ability to sit or stand for up to 8 hours per day, view computer monitor and move about between departments and buildings to effectively fulfill the essential functions of the job

Nice To Haves

Working knowledge of FDA QSR, ISO13485 or ISO9001 standards preferred
LIMS and/or SAP experience preferred

Responsibilities

Maintain policies and procedures to ensure regulatory compliance
Responsible for non-conforming material reporting and analysis system
Participate in resolution of quality issues within the manufacturing plant
Partner with other manufacturing and engineering departments to implement quality improvement projects
Generate reports and provides analysis and identifies trends
Provide training to individuals in the system as defined
Responsible for the CAPA system
Coordinate cross functional teams to provide structured root cause analysis and develop action plans
Facilitate timely implementation of actions
Support process improvement projects through implementation, including training on new processes and measurement systems
Follow up to ensure effectiveness of actions
Responsible for customer complaint systems including coordination of investigations and review of root cause analysis
Gather, analyze and distribute data from various quality system elements as assigned
Provide trending and analysis of quality related metrics
Apply mathematical/statistical concepts to understand and interpret data for trend analysis
Create or update procedures
Maintain procedures relevant to scope of job description
Participate and lead internal audits as a member of the facility internal audit team
Support and, if required, participate in third party audits
Define and implement continuous improvement processes within Quality Management Systems
Perform other related duties and assignments as required