Quality System Specialist I

Werfen; Bedford (MA); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k with employer match

Paid vacation and sick leave

Sales commission plan (where relevant)

Performance-based bonus (select roles)

Job summary

Werfen is seeking a Quality Assurance professional to support planning, coordination, and continuous improvement of the Quality Management System (QMS) ensuring GMP, FDA, and ISO compliance. You will monitor CAPA, audits, document control, and metrics under supervision of the Quality Systems Manager.

Minimum 1 year in a regulated medical device environment is required; a bachelor’s degree is essential. Occasional travel and collaboration with cross-functional teams are expected.

Qualifications

• Minimum of bachelor’s degree in related scientific or technical field.
• 1+ years of experience in medical device, IVD, or regulated industry.
• GMP knowledge with US FDA QSR and ISO 13485 familiarity is a plus.
• Strong MS Office and ERP (SAP) experience is a plus.

Responsibilities

• Assist CAPA tracking and trending, ensure root-cause analysis and effective verification.
• Support Internal Audit, supplier/audit activities and nonconformity closures.
• Maintain up-to-date Quality Agreements and communicate status with affiliates/distributors.
• Help maintain Quality Plans, External Documents tracking, and KPI data for Management Review.
• Support cross-functional QS activities and record-keeping across documentation.
• Attend QS-related meetings and contribute to process improvements.

Skills

Attention to detail

Accuracy

Delivery of results

Communication

Discretion

Multi-tasking

Collaboration

Independence

Professionalism

Takes initiative

Problem solving

Education

Bachelor’s degree in related field

Tools

Microsoft Office

ERP (SAP)

Job description

Werfen

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.

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

Job Summary

Responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support under the supervision of the Quality Systems Manager.

Key Accountabilities

• CAPA process – Assist with tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
• Internal Audit program – Assist with planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit.
• Quality Agreements – Assist with maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision
• Quality Plans – Assist with issuing number, creating plan, tracking status, timely/appropriate closure
• External Documents – Assist with tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans.
• Management Review – Assist with the creation and delivery of the Management Review presentation. Assist with completion and approval of the Management Review Meeting Minutes and closure of Action Items.

Secondary Functions

• Attend meetings related to QS activities
• Assist with change orders/process improvements with respect to Quality Management System procedures with direction from management
• Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
• Assists and supports internal, external (including regulatory) and/or 3 rd party audits, as needed
• Assists and supports duties in compliance with established business policies
• Other duties as assigned, according to the changing needs of the business

Networking/Key Relationships

• All Werfen Departments
• Werfen Affiliate QARA
• Werfen Corporate and other Werfen Manufacturer QARA

Minimum Knowledge & Experience Required for the Position

• Minimum of bachelor’s degree, in related scientific or technical field

Experience

• Minimum 1 years (or 1 years with advanced degree) of experience in the medical device, IVD or other regulated industry

Additional Skills/Knowledge

• Previous Quality Assurance experience within a GMP regulated environment is a plus
• Good understanding of US FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices & Good Documentation is a plus
• Good computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) is a plus
• Basic understanding of change control requirements
• Basic understanding of record retention

Skills & Capabilities

• Attention to Detail: Good ability to pay close attention to detail is required
• Accuracy: Work is accurate and completeness of records
• Outstanding Performance Standards: Demonstrated good ability to meet department goals
• Ethics and Values: Integrity and Trust / Ability to be Discrete
• Delivery of Results (Action Orientation): Good ability to Learn on the Fly / Taking Initiative
• Communication: Good written and verbal communication skills
• Discretion: Acts Honest, Loyal, Trustworthy
• Multi-Tasking: Good planning, organizational and time management skills are required to support changing business needs
• Collaboration: Good ability to work with cross functional teams
• Independence: Must be self-motivated and have the ability to work under minimal supervision; must also be able to work as part of a team
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
• Takes Initiative: Good ability to drive continuous improvement, correct deficiencies and to prevent recurrence
• Problem Solving: Good problem-solving skills are required

Travel Requirements

5% of time may be required for travel

The annual base salary range for this role is currently $65,000 to $80,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

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.

www.werfen.com