Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. 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.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Position Summary:

The Quality Systems (QS) Specialist II is responsible for assisting in the planning, coordination, control, and of key components of the Quality Management System (QMS), which helps to ensure compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS.

Key Accountabilities

Essential Functions:

The QS Specialist II will be expected to support all activities within the Quality Systems team shown below but will have primary responsibility for:

• CAPA process - tracking, trending of approved CAPAs, and driving timely/appropriate closure
• Deviation process - tracking, trending, and driving timely/appropriate closure
• Internal Audit program -transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure
• Quality Plans - issuing number, tracking status, appropriate closure
• Nonconformance process - assisting QE team with tracking, trending, and timely/appropriate closure

Quality Systems Activities:

• CAPA
• Deviation process
• External Document process
• Internal Audit program
• Nonconformance process
• Quality Agreements
• International QMS compliance with Werfen Affiliates
• Quality Plans
• Training program

Skills & Capabilities:

• Helps facilitate meetings related to QS activities by taking minutes as directed
• Supports change orders/process improvements with respect to Quality Management System procedures with direction from management
• Provides support to quality assurance activities for regulatory compliance, (i.e. management review support, regulatory audits)
• Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
• Participates in internal, external (including regulatory) and/or 3rd party audits, as needed
• Provides support through a general working knowledge of all Accriva quality system programs
• Aids employees based on a clear understanding and implementation of regulatory standards
• Carries out duties in compliance with established business policies
• Interface with all functions and levels of management as needed
• Other duties as assigned, according to the changing needs of the business

Education and Experiance:

• Bachelor's degree (Life Sciences) required
• Minimum of two (2) years related relevant experience required
• Previous Quality Assurance experience within a GMP regulated environment required
• Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred
• Technical writing background/experience is a plus

QUALIFICATIONS:

• Basic understanding of US FDA Quality System Regulations (QSR) is required
• Basic understanding of ISO 13485:2016 is required
• Good understanding of Good Manufacturing Practices & Good Documentation Practices
• Basic understanding of change control requirements
• Good understanding of record retention
• Computer literacy required; good working knowledge of Microsoft Office programs especially Power-point required.
• Strong planning, organizational and time management skills are required
• Ability to prioritize urgent matters

COMPETENCIES:

• Attention to Detail: Ability to pay close attention to detail is required
• Accuracy: Work is accurate and completeness of records
• Outstanding Performance Standards: Demonstrated ability to meet department goals
• Communication: Good written and verbal communication skills
• Discretion: Acts Honest, Loyal, trustworthy
• Multi-Tasking: Ability to Juggle Priorities, and support changing business needs
• Collaboration: Ability to actively develop a network to bring best solutions to the team or customer
• Independence: self-motivated-works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
• Takes Initiative: Serves as a role model for "Quality First" by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles issues and problems

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com