Quality Engineer I

Company Overview 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 position is an entry level position responsible to ensure that activities throughout the product lifecycle are compliant with procedures, standards, and regulations applicable to our products. This position, with direct guidance from manager or more senior staff, will work to achieve product quality goals and quality requirements in the areas of design, development, production, distribution, maintenance, and service. This is a technically focused role requiring skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls. Responsibilities Participates in the generation and review of quality documents throughout the product lifecycle Ensures product quality meets requirements and documentation is complete prior to approval Participates on core teams supporting new product development or design changes On new product development and or product performance investigations, provides guidance on tools and techniques available Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis. Advises regarding application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, production, distribution, and marketing of Werfen products. Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required. Other duties as assigned Secondary Functions Participates in quality system improvement projects as required. Internal Networking / Key Relationships Works closely with other functions to generate compliant documents in alignment with quality procedures, applicable standards, regulations, and best practices. Ability to negotiate and influence others in establishing direction toward improved quality and enhanced compliance. Skills & Capabilities Ability to read and interpret domestic and international quality/regulatory standards related to our products Demonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieve business objectives. Demonstrated understanding of risk-based approach to processes and decisions. Recognition of when to escalate issues to management or consult with more senior staff members. Ability and willingness to learn about products, processes and procedures relevant to role Competencies Attention to Detail: Ability to pay close attention to detail is required Accuracy: Work is accurate and complete Performance Standards: Demonstrated ability to meet department goals Communication: Excellent written, verbal and presentation skills Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality Multi-Tasking: Ability to manage multiple priorities, and support changing business needs Collaboration: Ability to work within a team 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 Decision making: Makes decisions based on data and risk determination Qualifications Bachelor’s degree or higher in engineering or science A minimum of 1 year of experience in a technical field or 0 years of experience with an advanced degree Duties necessitate basic knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing, and design engineering. Understanding of the application of technical principles and engineering problem solving to resolve complex issues. Language: English International Mobility: No Travel Requirements: Approximately 10% of time Compensation & Benefits 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, 401(k) 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 View email address on click.appcast.io for assistance. #J-18808-Ljbffr