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 About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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 The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.
