Design Assurance Engineer (f/m/d)

Cytiva; Grens; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Cytiva in Grens, VD, Switzerland, is seeking a Design Assurance Engineer to lead QA design activities for new product implementations, NPIs and transfers.

You will review design docs, support quality systems, and ensure compliance with QMS; travel up to 10% will be required for site activities.

Qualifikationen

• Bachelor’s degree in engineering or related field.
• 2–3 years in ISO 9001 medical devices or pharmaceutical industry.
• Experience with design change control and validation methodologies.
• Strong QA process knowledge with documentation focus.

Aufgaben

• Provide QA design support for NPIs and manufacturing transfers.
• Create and manage change control strategies and records.
• Review requirements, specs and design docs for feedback.
• Support development and improvement of manufacturing processes and quality systems.
• Write and approve site documentation for QMS compliance.
• Identify and address EHS, quality, or compliance issues and escalate as needed.

Kenntnisse

QA engineering

ISO 9001

Regulatory knowledge

Quality systems

English

French

Ausbildung

Bachelor’s degree in engineering

Tools

Minitab

Visio

Excel

Jobbeschreibung

The Design Assurance Engineer is responsible for QA Design activities for new product implementation, transfer of manufacturing and other QA related projects as needed.

This position is part of the Quality Department located in Grens in Switzerland (VD) and will be an on-site role.

What You Will Do

• Provide quality support and coordinate activities for collaboration programs with third parties and new product introductions (NPIs) as well as transfer of manufacturing projects.
• Create detailed, comprehensive and well-structured change control strategy and records.
• Review requirements, specifications and technical design documents to provide timely and meaningful feedback.
• Support the development, implementation, and continuous improvement of manufacturing processes and quality systems.
• Write, review and approve all new site documentation ensuring compliance with QMS.
• Suggest solutions to identified site problems to ensure consistent project execution.
• Develop process improvement plans using a variety of quality and continuous process improvement tools, including Process Mapping, Six Sigma, Lean Manufacturing, 5S, SPC, RCA, engineering studies, DOE, Gauge R&R, etc.
• Identify and report any EHS, quality or compliance concerns and take immediate corrective action or escalation as required.

Who You Are

• Bachelor’s (or higher) degree in engineering, health sciences, or related field.
• Minimum 2–3 years of experience in an ISO 9001, medical device or pharmaceutical industry in an engineering, quality, regulatory or R&D related role.
• Demonstrated understanding of product development lifecycles, design change, document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
• Ability to read and interpret professional journals, drawings and technical procedures.
• Solid QA process knowledge with an emphasis on technical skills to ensure understanding of technical data and information; experience with device/instrument hardware and software, and experience with single-use disposable kits is desirable.
• Proficiency with Microsoft tools: Word, Excel, PowerPoint, Project, Minitab, and Visio.
• Excellent verbal, written and presentation skills with the ability to communicate business issues clearly in English and French (spoken and written).

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel up to 10%.