Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage.

•Support Design Control activities by ensuring compliance with FDA and international regulations.

•Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments.

•Review protocols and participate in planning to ensure alignment with product requirements.

•Participate in protocol review and support testing strategy, ensuring robust verification and validation processes.

•Support Design Control activities by ensuring compliance with FDA and international regulations.

•Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures and operator self-inspection procedures.

•Works with other Quality Engineers and the Metrology Lab personnel on the development of all product gaging.

•Support the development and review of process and equipment validation/qualification (IQ/OQ/PQ) and MSA of internal processes.

•Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control.

•Interfaces with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.

•Assists with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. Participates in internal audits conducted by internal employees and regulatory agencies.

•Develop and execute supplier qualification processes, including supplier contracts and PPAPs.

•Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions (CAPAs).

EDUCATION and/or EXPERIENCE:

•Bachelor’s degree in Engineering, Quality, or a related field (Master’s preferred).

•5+ years of experience in medical device quality engineering or a related field.

•Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).

•Experience with Design Control, Process Validation, CAPA, and Supplier Quality.

•Proficiency in statistical analysis tools (Minitab, JMP, Excel) /and problem-solving methodologies (8D, DMAIC).

•Certified Quality Engineer (CQE) or Six Sigma certification is a plus.

KEY COMPETENCIES: (Leadership skills/behaviors)

Building Strategic Working Relationships-Developing and using collaborative relationships to facilitate the accomplishment of work goals.

Quality Orientation-Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.

Decision Making- Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.

Performance/Work Standards-Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks. (Flawless Execution of the Basics).

Information Monitoring- Setting up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.