This Quality Engineer II is a hands-on quality engineering role supporting production operations, process controls, inspection systems, and manufacturing quality improvements within Edwards' precision machining operations. This position partners closely with Manufacturing Engineering, Operations, and New Product Introduction teams to ensure product quality, process stability, and successful product transfers into commercial production.
The ideal candidate brings experience owning nonconforming material investigations, CAPAs, manufacturing quality systems, process validation activities, and production line support within a regulated manufacturing environment. Experience supporting machine operations, MES systems, and continuous improvement initiatives is highly desirable.
How You'll Make an Impact:- Investigate moderately complex manufacturing product quality and compliance issues which may include:
- Investigating PRAs and complaints for manufacturing related 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 on hold (MRB), and manage material quality control.
- Review and approve equipment validations and asset management actions.
- Optimize to 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
- May 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
- Provides 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
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
What Else We Look For (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.
