Manufacturing Quality Engineer II, Sustaining (2nd Shift)

What You'll Need (Required)

• Bachelor’s degree in engineering or a scientific field with 2 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or related experience in a regulated manufacturing environment
• OR Master’s degree in engineering or scientific field with no experience (or internship/co-op experience)
• Experience owning NCRs and CAPAs
• Ability to work onsite (100%) during the designated 2nd-shift schedule (Monday - Thursday, 3:30 PM-2:30 AM)

What You'll Need (Preferred)

• Engineering degree
• Highly regulated manufacturing environment experience (medical device highly preferred)
• Experience supporting manufacturing operations, production processes, or sustaining engineering activities
• Experience investigating and resolving quality issues through structured problem-solving methodologies
• Strong understanding of MRB processes, quality metrics, and continuous improvement methodologies
• Familiarity with Manufacturing Execution Systems (MES)
• Hands-on involvement with precision machining environments, including CNC and Swiss machining operations
• Proficiency with Keyence inspection systems, vision systems, or automated inspection technologies
• Background supporting new product introduction (NPI), manufacturing transfers, product launches, and production stabilization
• Working knowledge of process validation activities, including IQ/OQ/PQ and manufacturing process controls
• Understanding of SPC, pFMEA, risk management, root cause analysis, and statistical problem-solving techniques
• Knowledge of Lean Manufacturing, Six Sigma, and continuous improvement tools
• Demonstrated ability to collaborate effectively with Operations, Manufacturing Engineering, Quality Control, and cross-functional stakeholders
• Familiarity with FDA Quality System Regulations, ISO 13485, and regulated manufacturing quality systems

How You'll Make an Impact

• Investigate moderately complex manufacturing product quality and compliance issues
• Manage site NCRs, CAPAs, ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results
• Provide technical support to external and internal audits
• Make recommendations and develop reports
• Oversee product release, assess and disposition product onhold (MRB), and manage material quality control
• Review and approve equipment validations and asset management actions
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement
• Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Collaborate with engineering teams to ensure successful transfers
• Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Support for the following: Process validation or support/lead TMV, sustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control etc, PMV, Process Validation plans
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work
• Other incidental duties assigned by Leadership