Manufacturing Quality Engineer

About the role

Under the direction of the Quality Manager, ensures compliance with company Quality Management Systems and customer requirements in accordance with ISO 13485, and provides quality engineering support to manufacturing.

Responsibilities

• Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607
• Support manufacturing units with analyzing failures, preventive and corrective action processes related to both internal and external issues
• Facilitate Failure Mode and Effect Analysis (FMEA)
• 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)
• Aid in the engineering change order process
• Conduct audits, including closing out audit findings, creating audits finding reports and determining proper corrective and preventive actions
• Provide support to the Quality manager in establishing, implementing and maintaining the quality management system
• Develop and perform: Validations, FMEA, Root Cause Analysis, Gauge R&R, and DOE

Requirements

• Bachelor’s degree in Engineering or Science preferred
• Two or more years of Quality Engineering Experience (medical or food flexible packaging preferred)
• Six Sigma Green or Black Belt certification (preferred) or willingness to pursue

Qualifications

• Ability to work cross-functionally with Process Engineering, Operations and Product Development departments
• Excellent interpersonal and communication skills
• Results oriented, multi-tasking, and able to respond to urgent needs and meet deadlines
• Strong organizational skills and ability to work well independently and as a member of a team
• Strong statistical background and working knowledge of SPC software (Minitab preferred)
• PC Oriented (MS Office)
• Working knowledge of ISO-13485 or ISO 9001 QMS
• R and FDA Medical Devices Regulations

Skills

• Ability to work cross-functionally with Process Engineering, Operations and Product Development departments
• Excellent interpersonal and communication skills
• Results oriented, multi-tasking, and able to respond to urgent needs and meet deadlines
• Strong organizational skills and ability to work well independently and as a member of a team
• Strong statistical background and working knowledge of SPC software (Minitab preferred)
• PC Oriented (MS Office)
• Working knowledge of ISO-13485 or ISO 9001 QMS
• R and FDA Medical Devices Regulations

Benefits

• Medical, dental and vision plans
• Flexible time off, starting at 80 hours paid time per year for full-time salaried employees
• Company-paid holidays starting at 8 days per year and may vary by location
• Wellbeing program & Employee Assistance Program
• Health Savings Account/Flexible Spending Account
• Life insurance, AD&D, short-term & long-term disability, and voluntary benefits
• Paid Parental Leave
• Retirement Savings Plan with company match
• Tuition Reimbursement (dependent upon approval)
• Discretionary annual bonus program (initial eligibility dependent upon hire date)