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.

The Quality Engineer is the subject matter expert for Software as a medical device (SAMD) and/or software as an accessory/component to a medical device, and ensures the software is compliant with all regulations. This role oversees implementation of the project quality management plan(s) and product plans of the organization. He/She helps to ensure the quality, compliance, and integrity of GXP systems used in the development, manufacturing, and distribution of medical devices / In vitro devices (IVD). The role also manages projects from concept to completion; creates and manages project plan, work cross functionally to ensure completion, and ensure adequate training to impacted areas. He/She works effectively with stakeholders to ensure alignment with business objectives, correct prioritization, and successful project delivery and assists with product and process validations, including protocol and report review. If you have the required skills, don't wait, apply today!!

(This is NOT AN IT POSITION)

This position is not eligible for sponsorship for work authorization. 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 Engineer/Medical Device/ IVD Software

Key Accountabilities:

Quality reviewer of software revision documentation, such as user acceptance testing and software testing/qualification. Work with software team during design updates.
• Ability to lead a cross-functional core team in successfully delivering to system-based projects and process improvements. Collaborate cross-functionally to create and execute project plans (scope, schedule, staffing plans, quality, risk management, budget, and procurement) and revise them appropriately to meet changing needs and requirements.
• Ensure that upgrades to medical device reagents and software are made in compliance with all applicable regulations. Support quality and regulatory teams in creating/revising technical documentation related to IVDs (reagents and software) and support deliverables required to meet country registration requirements.
• Monitor, analyze, and report on GXP system metrics and identify trends and areas for improvement.
• Support risk management practices and concepts and applies knowledge to manufacturing operations and software development. Support risk management program associated with commercial and development medical devices.
• Engage in the development and improvement of the internal manufacturing processes for existing and new products. Ability to simultaneously manage commercial and development projects.
• Update and maintain Design History Files / Technical documentation as needed. Including editing and review of impact and risk assessments for design, process, and risk control activities.
• Ensure integration of product regulatory requirements into product specifications and technical documentation.
• Partner with internal functional areas as part of the change control process. Support CAPAs and change control associated with product improvements.
• Support QA and RA on projects as needed.

Quality Engineer/Medical Device/ IVD Software

Minimum Knowledge & Experience required for the position:

• Bachelor's degree in biomedical engineering, biology, chemistry, engineering, or related field.
• Five or more years' experience within a pharmaceutical and/or medical device company in a quality assurance role (IVD experience preferred).
• Graduate degree may substitute for some of the experience, depending on the coursework and pharmaceutical and/or medical device experience in a quality assurace role
• At least 2 years experience with software as a medical device (SAMD) and/or accessory to a medical device, required
• Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Experience with 21 CFR Part 820, ISO 13485, and/or MDSAP
• Experience with 21 CFR Part 210/211 may be accepted depending on other related experience.
• Experience with IVDR (EU 2017/746) / MDR (EU 2017/745) regulations preferred.
• CQE certification, preferred

Quality Engineer/Medical Device/ IVD Software

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