Quality Engineer – Process Development

Join our team in Northridge CA a vibrant community with a rich cultural heritage and a hub for innovation in the medical device industry. We are seeking a dedicated professional to support new product introduction (NPI) and production scale-up activities within the diabetes medical device space.

This individual will drive process validation strategies lead process risk management (PFMEA) and serve as a critical cross-functional liaison between internal Supplier Quality R&D Contract Manufacturers and NPI teams. The ideal candidate brings deep expertise in process development FMEA methodologies and regulatory compliance. A proven track record of resolving critical production issues during scale-up and mentoring engineering teams is essential.

• Develop P-diagrams Input-Process-Output (IPO) matrices process characterizations and test method validation (TMV) strategies for NPI programs.
• Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.
• Apply methodologies including Design for Reliability and Manufacturability (DRM) Design for Six Sigma (DFSS) Design for Manufacturing Assembly (DFMA) and Cell Operating System (COS).
• Drive risk mitigation approaches by integrating qualification parts early in process development phases.

• Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up.
• Maintain strong working knowledge of design risk documentation (RAD DFMEA HRA) to critically analyze process-related failures and identify gaps.
• Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk assessment decisions.
• Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition.
• Conduct thorough root cause investigations using A3 Problem Solving methodology fishbone diagrams 5-Why analysis and brainstorming techniques.

• Serve as the primary quality interface between internal Supplier Quality Engineering (SQE) R&D cross-functional teams Contract Manufacturers and NPI program teams.
• Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans inspection criteria and risk documentation.
• Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer.
• Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness.
• Ensure alignment between contract manufacturers and internal teams on deliverables expectations and quality standards.
• Bridge QMS gaps between contract manufacturing partners and internal quality systems standardizing documentation templates and expectations.
• Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections.

• Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization.
• Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA).
• Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues.
• Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines.

• Perform statistical analyses including hypothesis testing confidence and tolerance intervals regression capability analysis DOEs and GR&R using Minitab.

EEO Employer

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race color sex religion sexual orientation national origin disability genetic information pregnancy or any other protected characteristic as outlined by federal state or local laws. This policy applies to all employment practices within our organization including hiring recruiting promotion termination layoff recall leave of absence compensation benefits training and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications merit and business needs at the time.