Quality Engineer

Location: Somerset, NJ (Hybrid)

Position Responsibilities:

• 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.

Your Qualifications:

• 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. Working knowledge of FDA QSR, ISO13485 or ISO9001 standards preferred.
• 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. LIMS and/or SAP experience preferred.
• Competent in utilizing statistical analysis tools.

Physical Demands:

• 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.

Equipment & Machinery Used:

• Desktop or lap top computer.

Benefits Offered

• Medical plan
• Prescription drug coverage
• Dental plan
• Retirement savings plan
• Disability benefits
• Flexible spending