Quality Assurance Technical Writer

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.

Job Summary

Create, revise, and review product technical documentation (including product design, validation, and regulatory submissions). Review documentation to ensure that all quality and regualtory requriements are met. Supports activities which lead to and maintain both domestic and international regulatory approval to market devices. In addition, performs a variety of managerial tasks and projects to ensure quality system compliance with US FDA Quality System Regulations, EU IVDR, MDSAP, Canadian Medical Devices Regulations, IVD Directive (98/79/EC), other applicable international medical device regulations and ISO 13485.

Key Accountabilities

• Create, revise, and review product technical documentation (including product design, validation, and regulatory submissions).
• Create, revise, and review company procedures to align with global reguations.
• Learn the company's products in sufficient detail in order to be able review product documentation.
• Serve as quality technical representative on cross function teams, including product development teams.
• Support revision of technical documentation for IVDR (EU 2017/746) product certification.
• Revise and approve product documentation as needed to support global regulatory submissions.
• Support action item activities related to CAPA and change control.
• Support other quality system activities.
• Stay up-to-date on global IVD regulations.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• This role will work often with cross functional teams including the following:
  • Project Management
  • R&D and MTS (Manufacturing Technial Support)
  • Operations
  • RA/QA counter parts globally

Minimum Knowledge & Experience required for the position:

Education:

• Bachelor's degree in a science related field (ex. biology, biomedical, molecualr biology)

Experience:

• Five (5) or more years of experience in quality assurance in a pharmaceutical or medical device industry. Three (3) years of experience in technical writing. Experience with IVDR technical documentation preferred.
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Experience creating/revising documentation in alignment with global medical device regulations: 21 CFR Part 820, ISO 13485, MDR/IVDR (2017/745 and 2017/46)
• Strong interpersonal, organizational, and communication skills
• Self-starter; ability to participate in cross-funcitional teams
• Ability to set objectives and organize work to achieve goals
• Must be able to work within an evolving environment
• Must be able to accept change to work schedule on a daily basis
• Excellent communication skills, both oral amd written
• Well-versed in Microsoft Office applications
• Experience using MasterControl preferred

Travel Requirements:

• Travel is not routinely required for this position (<5%)

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

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 NAtalentacquisition@werfen.com 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