Senior Quality Assurance Specialist, Medical Devices

Werfen; Wisconsin; Sur place; USD 78 000 - 105 000; Plein temps

Résumé du poste

Werfen in Wisconsin seeks a Quality Assurance Specialist to ensure compliance with domestic and international standards. You will lead QA activities across design control, change control, CAPA, and validation, mentoring staff and interfacing with multiple departments.

You will review quality outputs, support audits, and drive continual improvement within ISO 13485 and cGMP frameworks, contributing to product quality and regulatory success.

Qualifications

• Bachelor's degree in Life Sciences, preferably Biology or Chemistry.
• 3-5 years’ experience in Quality Assurance.
• QA experience in the medical device industry, a plus.
• Certificates such as CQA and CQE, a plus.
• Advanced knowledge of CAPA, Validations, Design Control and Change Control.
• Working knowledge of ISO 13485, 21CFR820 or cGMP.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to work effectively in a cross-functional environment.
• Ability to integrate quality objectives across multiple functions.

Responsabilités

• Conducting compliance audits of complex documentation and data
• Serving as QA interface to other departments and/or partners
• Managing, mentoring and training staff in our quality system procedures and the general regulatory compliance requirements associated with in‑vitro diagnostic medical devices
• Reviewing quality outputs for compliance to internal and external requirements (21 CFR 820, ISO 13485, ISO 14971, etc.)
• Assisting in chairing meetings such as Material Review Board and Product Quality Committee
• Preparing appropriate agendas and meeting minutes with limited supervision
• Monitoring progress of meetings and reporting progress
• Developing, maintaining and reporting department metrics
• Reviewing and assessing appropriateness of document changes in accordance with internal procedures
• Reviewing and assessing change control, validation and qualification documents
• Contributing to CAPA and NCR System, including reviewing adequacy of root cause, corrections, corrective actions, preventative actions and effectiveness
• Reviewing and owning CAPA records
• Identifying and leading continual improvement projects with cross‑functional team members
• Developing and implementing quality system processes from a site level perspective

Connaissances

Quality control

QA processes

Cross-functional collaboration

Documentation

Problem solving

Formation

Bachelor’s degree in Life Sciences (Biology or Chemistry)

3-5 years QA experience

CQA

CQE

Outils

Microsoft Word

Excel

PowerPoint

Outlook

CAPA

Change Control

cGMP

ISO 13485

21 CFR 820

Description du poste

Werfen in Wisconsin seeks a Quality Assurance Specialist to ensure compliance with domestic and international standards. You will lead QA activities across design control, change control, CAPA, and validation, mentoring staff and interfacing with multiple departments.

You will review quality outputs, support audits, and drive continual improvement within ISO 13485 and cGMP frameworks, contributing to product quality and regulatory success.