What are the responsibilities and job description for the Regulated Manufacturing Engineer position at Trelleborg Medical Solutions?
About the Company:
Trelleborg Medical Solutions is a leading provider of innovative solutions for the medical device industry. Our company is committed to delivering high-quality products and services that meet the evolving needs of our customers.
Your Key Responsibilities:
- Collaborate with the NPD team to develop and execute equipment, software, test method, and/or process validation strategies.
- Identify, estimate, evaluate, control, and monitor 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.
