Quality Specialist III

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

Country

United States

Shift

1st

About the Position

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care

Overview

We are seeking a Quality Specialist (Quality Assurance Specialist) to join our team at our Waukesha, WI facility. This position is not eligible for sponsorship for work authorization by Werfen. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Quality Assurance Specialist – Quality Specialist – Medical Device Technology (QA)

Responsibilities

As a Quality Specialist (Quality Assurance Specialist), you will be responsible for ensuring compliance with applicable domestic and international standards and regulations through process review, approval, audits and systematic maintenance of quality systems. You will function as a product development process QA and Change Control team lead, ensuring compliance to all internal and external design control requirements. The scope and design of your control activities include software development, design inputs and outputs, risk management, verification, validation, design transfer (manufacturing, suppliers and service), change management, design review, and review of design history files. You will also be a QA liaison for validation and verification activities.

Other responsibilities include:

• 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

Quality Assurance Specialist – Quality Specialist – Medical Device Technology (QA)

Qualifications

As a Quality Specialist (Quality Assurance Specialist), you must have working knowledge of quality control, manufacturing and inventory processes as well as QSR and ISO requirements. It is important that you possess good communication and technical skills including working knowledge of Microsoft Word, Excel and related functions including formulation of graphs. Additionally, qualified candidates have the ability to communicate effectively and professionally with all customers as well as encourage teamwork among coworkers.

Other requirements of the QA role include:

• 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
• Attention to detail, strong organizational skills, and time management are essential

Quality Assurance Specialist – Quality Specialist – Medical Device Technology (QA)

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.