Senior Quality Engineer

Position Overview

Senior Quality Assurance Engineer role will apply diversified knowledge of engineering, quality principles, and practices for medical device products and in‑vitro diagnostic devices (EU and FDA). Responsible for ensuring system‑level project deliverables—plans, requirements, specifications, tests, test results, traceability, risk management documents, and reports—meet quality and compliance requirements.

Must work in a team environment and communicate across all disciplines including R&D, Regulatory Affairs, Post‑Market Surveillance, Manufacturing, Validation, and Regulatory Agencies. This position is not eligible for sponsorship for work authorization.

• Lead risk management initiatives for the entire product lifecycle in accordance with ISO 14971 and related regulatory requirements.
• Independently manage and facilitate new risk assessments from initiation to completion, working cross‑functionally to develop robust and compliant risk management plans.
• Collaborate at a system level with R&D, Clinical, and key functions to identify risks, implement risk control measures, and document a robust, living risk management file.
• Review and provide feedback for changes to designs and processes, assessing their impact to ensure risk management requirements are met.
• Support ongoing product compliance technical documentation and market authorizations through review and response to competent authority feedback in a timely manner.
• Assist teams in establishing product development requirements such as Design Input Documents, Design Verification & Validation requirements, Risk Management documents, Usability requirements, and CTQ Identification.
• Support design history file (DHF) content completion, collaboratively communicating and resolving regulatory compliance gaps.
• Serve as a Quality Core Team member on sustaining product lifecycle projects and new product development teams, representing Quality for product improvement, manufacturing transfers, and quality plan initiatives.
• Assist in QA review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
• Assist in QA review and approval of software user acceptance testing.

• Minimum of 5 years medical device experience in a Quality or R&D Engineering position with risk management, design control, and product development experience.
• Experience in the IVD industry preferred.
• Bachelor’s degree (BA/BS) from a four‑year college or university; or equivalent combination of education and experience.
• BS in Engineering or an associated scientific discipline preferred.
• Quality certification such as CQE, CQA, ASQ, or SSBB preferred.
• Proficient in Microsoft Word, Excel, and managing electronic data files.
• Extensive hands‑on experience with ISO 14971, demonstrated implementation of a device risk management process based on the standard.

• Strong working knowledge of risk management, CAPA, and Design Controls.
• Some experience in systems engineering and/or device development, including connected systems and software as a medical device (SaMD).

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 N for assistance.