NPD Quality Engineer

Trelleborg Sealing Solutions Switzerland AG; Delano (MN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k plan

Paid time off

Tuition reimbursement

Job summary

Trelleborg Medical Solutions is seeking an NPD Quality Engineer to plan and coordinate quality engineering activities for medical device development, including validation and regulatory compliance.

Collaborate with NPD teams to support equipment qualification, software validation, test method development, IQ/OQ/PQ, and other quality processes to ensure FDA, ISO 13485 and EU/MDR compliance across development projects.

Qualifications

• 4-year degree in quality, engineering or related field.
• 2+ years in a manufacturing environment in a technical support role.
• ASQ Certified Quality Engineer.
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, FDA 21 CFR 820/11, EU/MDR.

Responsibilities

• Plan, develop and execute equipment, software, test method and process validation strategies.
• Support NPD teams to ensure quality processes across design and development phases.
• Monitor and report project deliverables to prevent delays.
• Perform risk management using PFMEA.
• Author or approve protocols and reports for IQ/EQ, SV, TMV and OQ/PQ.
• Review specifications, drawings, quality agreements and customer documents.
• Plan, coordinate and oversee Test Method Development activities.
• Collaborate with Metrology to define inspection methods and sampling.
• Perform MSA, GRR, bias and linearity studies and other statistics.
• Conduct DOE, ANOVA and Capability analyses on inspection data.
• Develop Quality Plans and address deviations and CAPAs.
• Ensure compliance with QMS for validation docs and records.
• Support engineering, manufacturing and inspection with quality control.
• Communicate with customers on specs and changes as needed.
• Understand regulatory requirements (ISO13485, 9001, 14971, FDA 21 CFR 820, EU/MDR, ITAR).
• Provide direction to QA inspectors and technicians.
• Support audits and CAPA activities.

Skills

pFMEA

Gage R&R

DOE

ANOVA

Quality engineering

Statistical analysis

MSA

IQ/OQ/PQ

GMP/ISO knowledge

Regulatory compliance

Education

4-year degree in quality/engineering or related field

Tools

IQ/OQ/PQ tools

Gage measurement tools

Job description

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.

As a valued team member with Trelleborg, you will enjoy:

• Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
• Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
• Greater opportunity for impact: You will have the autonomy and support to lead the production team and impact the production of life‑saving devices.
• Growth and advancement: Join a global company that loves to promote from within and allows for advancement.

Qualifications:

Required

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

ASQ Certified Quality Engineer

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.

Qualifications

Skills

Behaviors

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Motivations

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Education

Experience

Licenses & Certifications

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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