Werfen North America · 1 week ago
Principal Design Quality Engineer - Transfusion and Transplant
Norcross, GA
Full-time
Onsite
Senior Level, Lead/Staff
7+ years expWerfen North America is a growing, family-owned, innovative company and a worldwide leader in specialized diagnostics. The Principal Design Quality Engineer will ensure the quality of products throughout the design and development process, lead quality improvement initiatives, and mentor other quality engineers.
Health CareManufacturing
Responsibilities
Authoring and overseeing quality plans that meet compliance standards, including those related to product design, safety and reliability
Leading the process to ensure designs adhere to regulatory and quality requirements, including risk management activities
Overseeing design verification and validation activities, including testing, analysis and reviews
Leading and driving continuous improvement initiatives to enhance product quality, efficiency and customer satisfaction
Providing leadership and mentor-ship to other engineers, fostering a culture of quality and safety
Lead risk management initiatives for the entire product life-cycle in accordance with ISO 14971 and related regulatory requirements. Assure applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system
Support on-going product compliance technical documentation and on-going market authorization through review and response to competent authority feedback in a timely manner
Support teams to establish product development requirements (e.g. Design Input documents, design verification and validation requirements, risk management requirements, usability requirements, CTQ Identification, etc.)
Serve as a Quality core team member on sustaining product life-cycle projects and new product development teams. Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives
Performs other duties and responsibilities as assigned
Qualification
Required
Minimum Bachelor's degree in Engineering (Bio Medical Preferred) or related scientific field
7 yrs minimum (Preferably Medical Device Industry)
Able to work in a team environment and collaborate
Demonstrates knowledge of products, services, procedures, policies, systems and company organization as it relates to job requirements
Display PC skills with Microsoft Office (Word, Excel) and other desktop functions at an intermediate level
Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience
Excellent teamwork skills including influencing and building rapport with internal departments and stakeholders
Excellent problem solving skills, including demonstrated critical thinking skills and application of structured problem solving methods and tools
Able to lead and make independent decisions in collaboration with cross functional teams
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase