Description:

　　Process validations (IQ, OQ, & PQ) and product validations

　　Support manufacturing units with analyzing failures, preventive and corrective action processes

　　Facilitate FMEA (Failure Mode and Effect Analysis)

　　Perform Design of Experiments (DOE)

　　Track, trend and report quality metrics

　　Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.

　　Provide support for the implementation and sustaining of statistical process controls (SPC)

　　Provide support to engineering change order process

　　Assist in establishing, implementing and maintaining the quality management system.

　　Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions

　　Ability to effectively develop and perform: Validations, FMEA, Root Cause Analysis, Gauge R&R, and DOE

　　Additional Skills & Qualifications:

　　Bachelor’s degree

　　0-5 years of Quality Engineering Experience (medical or food flexible packaging preferred)

　　Six Sigma Green or Black Belt certification (preferred) or willingness to pursue

　　Work cross-functionally with Process Engineering, Operations and Product Development departments

　　Excellent interpersonal and communication skills

　　Must be results oriented, multi-tasking, and be able to respond to urgent needs and meeting deadlines

　　Must have excellent organizational skills and the ability to work well both independently and as a member of a team

　　Working knowledge of SPC software (Minitab preferred)

　　PC Oriented (MS Office)

　　Must have working knowledge of ISO-13485 or ISO 9001 QMSR and FDA Medical Devices Regulations

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.