Job Description

Responsibilities:

• 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 V&V 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 (Company) and corrective & preventive actions (CAPAs).

Requirements:

• 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.
• 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.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information

All your information will be kept confidential according to EEO guidelines.