What are the responsibilities and job description for the Quality Assurance Specialist position at Trelleborg Medical Solutions?
About Trelleborg Medical Solutions:
We are seeking a highly skilled NPD Quality Engineer to join our team. As a key member of our New Product Development (NPD) team, you will be responsible for planning and coordinating quality assurance activities for medical device manufacturing through the design and development phases.
Your Key Responsibilities:
- Develop and execute equipment, software, test method, and/or process validation strategies in collaboration with the NPD team.
- Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk using tools such as Process Failure Modes and Effects Analysis (pFMEA).
- Autor or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ).
- Review and evaluate specifications, drawings, quality agreements, customer documentation, and other documents to support NPD projects.
- Plan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised products.
- Develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications.
- Perform measurement system analysis (MSA), Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies.
- Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis.
- Author and execute Quality Plans for Quality Management Systems and Organizational Objectives projects.
- Initiate and perform root cause analysis, using statistical and capability analysis to solve problems.
- Adhere to the company's Quality System (QS), write, and approve QS documents.
- Review and ensure compliance with QMS of all validation documents and records.
- Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product.
- Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed.
- Understand regulatory requirements, e.g., ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR.
- Provide periodic work direction and assistance to QA inspectors, QA technicians, and Quality Engineering Technicians.
- Support other quality activities as necessary, such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA).
- Support internal and external audits.
About the Role:
The ideal candidate will have a strong background in quality engineering and experience working in a regulated manufacturing environment. They will possess excellent communication and project management skills, as well as the ability to collaborate effectively with cross-functional teams.
What We Offer:
- A competitive salary based on experience.
- A comprehensive benefits package, including health, dental, vision, STD, LTD, life, and 401k.
- Opportunities for professional growth and development.
