Staff Quality Engineering

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.

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

Bring your expertise in compliance, design controls, assay design, and system integration principles to the forefront of quality, science, and impact. As a Staff Quality Engineer within Werfen's Autoimmunity business, you will play a pivotal role in ensuring the safety, efficacy, and regulatory excellence of innovative IVD and medical device products. Partnering closely with R&D, Manufacturing, and crossfunctional leaders, you will help implement quality strategy across the full product lifecycle-from design and development through postmarket surveillance-while driving continuous improvement and influencing critical decisions. This is a highly visible individualcontributor role for a seasoned quality professional who thrives on technical challenge, mentorship, and shaping robust, auditready systems in a fastpaced, evolving environment.

Key Accountabilities

• Teamwork: Coordinate other functional areas of the company on design and development projects, product and process changes, risk management, root cause investigations, validations, process capability, trend analysis, and statistical process Develop, improve, implement, and maintain Quality Management procedures that ensure design and development, production, and post-production (post market) activities efficiently define, meet, and maintain customer, technical requirements, and regulatory requirements with objective evidence in accordance with applicable regulations and standards per company goals. Define and drive improvement projects and initiatives that reduce systemic manufacturing defects; improve quality systems.
• Product and Process Life Cycle: Represent Quality Engineering in Design and Development activities through launch, product and process changes, sustaining on-Market safety and efficacy, and post-market surveillance endeavors. Provide subject matter expertise and ensure the delivery of objective evidence using scientific methodology including technical validity, accuracy, completeness, and compliance to applicable regulations and standards in QMS areas such as product and process development, specification development, acceptance methods development, design transfer, design validation, process validation, risk management, product realization, packaging and shipping validation, product launch, and nonconformance assessment.
• Risk Management: Maintain QMS procedures that facilitate risk management activities and produce audit ready risk file documents in compliance with the requirements of current international risk management standards and regulations.
• Quality Science and Engineering: Perform independent quality review and evaluation of change orders including related data for scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance to applicable regulations and standards. Provide guidance on identified gaps and collaborates to determine remediation activities. Apply critical analytical thinking in the investigation process specifically during root cause analysis, risk assessment evaluation and determination corrective and preventive actions determination to guarantee gaps are properly addressed. Provide consensed Quality input into process investigations using a systematic approach to ensure root causes and CAPAs are aligned. Collect and analyze defined quality metrics, quality-related data to identify issues or trends.
• Quality Management Systems: Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Aid in designing and documenting new and revised quality systems for product realization compliance with applicable regulations and standards. Ensure QMS processes, procedures, and quality documentation to maintain a state of audit readiness. Escalate events that may contribute negatively to medical devices safety or efficacy. Address and remediate events that may contribute negatively to QMS processes or effectiveness. Apply critical analytical thinking in the investigations and nonconformance systems specifically during root cause analysis, risk assessment evaluation, and corrective and preventive actions determination to guarantee that (potential and actual) nonconformances are properly addressed. Support other functions in resolving on quality systems issues and concerns.
• Audit: Support internal, and third-party audits, regulatory inspection preparation and execution. Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
• Ensure compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.
• Reflect the values of Werfen and Inova in the quality of work and in working relationships.

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

Networking/Key relationships

• Manufacturing teams
• Regulatory teams
• R&D teams including Manufacturing Technical Support
• Contract manufacturers
• Quality Assurance
• Quality Control
• Suppliers
• Staff and Executive Management
• Affiliates
• Other Werfen Manufacturer's Quality Engineering functions

Minimum Knowledge & Experience for the position:

Education:

• Bachelor's degree in a life science, engineering, or equivalent required. Advanced degree preferred
• Six Sigma/Lean Black Belt certification, preferred.
• ASQ Certifications for Certified Quality Engineer, (CQE), Certified Supplier Quality Professional (CSQP) Risk Management Specialized credential, or Quality Manager (CQM) preferred.

Experience:

• Ten (10) or more years of work experience in IVD or medical device industry required.
• Six (6) year of work experience in Quality Engineering in the designated specialty of Design Quality Engineering for IVD assay reagents, Risk Quality Engineering, or related functions required.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Advanced knowledge of current compliance requirements (e.g., US Quality Management System Regulations (QMSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, ISO 17025, IEC 60825 or other regulations and standards).
• Advanced knowledge in the following:
  • Multi-disciplines: design controls, risk assessment and analysis, root cause investigations, trend analysis, statistical sampling, change control assessment, nonconformance assessment, design of experiments, project management, and data mining.
  • Design Quality Engineering for IVD assay reagents: IVD functional principles for ELISA, IFA, CIA, and microspheres, material qualification, reagent stability and artificial intelligence applications.
• Advanced ability to interpret and apply compliance and quality management requirements.
• Advanced ability to organize and complete multiple tasks in a fast-paced environment as a team member and/or as an individual contributor in a timely, accurate manner under general supervision.
• Advanced ability to function effectively with ambiguity in a rapidly changing environment.
• Advanced abilities in influencing and negotiation while building collaborative relationships and maintaining strong, positive working relationships.
• Advanced ability to develop proactive and creative approaches to problem solving.
• Advanced skills in verbal and written communication including technical writing.
• Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.

Travel requirements:

Limited to no travel required

Compensation:

The annual base salary range for this role is currently $135k to $165k. 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.

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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