NPD Quality Engineer

Trelleborg Group•Delano, CA

2d•Onsite

About The Position

Trelleborg Medical Solutions is seeking a NPD Quality Engineer to join their team. The NPD Quality Engineer is responsible to plan and coordinate quality engineering activities for medical device manufacturing through the design and development phases including validation for new product development. Collaborate with other New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturing. Working with internal and external customers to support creative approaches and solutions to problems.

Requirements

4-year degree in quality, engineering or any related field
2+ years in a manufacturing environment in a technical support role

Nice To Haves

ASQ Certified Quality Engineer
Formal Six Sigma Yellow/ Green belt training
Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable), EU/MDR.

Responsibilities

Knowledgeable and adheres to TMS Quality Management System and its requirements.
Works with the NPD team to plan, develop and execute equipment, software, test method, and/or process validation strategy
Monitors and reports out on project deliverables to ensure timely completion; escalates issues, questions, and concerns, immediately to prevent project delays.
Performs risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA)
Authors or approves protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ).
Reviews and evaluates specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects
Plans, coordinates, and oversees Test Method Development activities; initiates inspection plans for new/revised product.
Works with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications
Performs measurement system analysis (MSA) Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies
Performs statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis
Authors and executes Quality Plans, when needed
Support resolution of deviations and nonconforming issues arising during development; completes investigations and perform root cause analysis.
Reviews and ensures compliance with QMS of all validation documents and records
Supports Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product
Communicates with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects, as needed.
Understands regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, EU/MDR, ITAR)
Provides periodic work direction and assistance to QA inspectors and QE Technicians
Supports other quality activities such as customer complaints, MRBs, and CAPAs
Drives best practices through the application of effective quality engineering principles and procedures across functions.
Supports internal and external audits.
Other duties as assigned.