Overview
The Senior Quality Management Systems Engineer is responsible for maintaining, improving, and ensuring compliance of the company’s Quality Management System in accordance with ISO 9001, ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.  This role supports continuous improvement initiatives, internal and customer audits, CAPA processes, and documentation control to ensure product quality and regulatory compliance.
This position is responsible for developing and maintaining the company’s QMS documentation including SOPs, work instructions, and related forms and specifications The position is also responsible for ensuring individuals within the company are effectively trained to the QMS documentation applicable to their roles and responsibilities.
Principal Responsibilities
Quality System Maintenance & Compliance

• Maintain and improve the company’s Quality Management System (QMS) to ensure compliance with ISO 9001, ISO 13485, FDA QSR, MDR, and other applicable global regulations.
• Develop, revise, and implement quality system procedures, work instructions, and forms.
• Support management review system through the monitoring of quality data, development and analysis of quality metrics, and development and presentation of actionable reports on the status of product quality and QMS compliance.
• Initiate QMS improvements, as needed.

Audits, CAPAs, NCMRs, and Complaints

• Prepare for and support internal, supplier, and external audits (e.g., FDA, Notified Body, Customers).
• Manage and support CAPA (Corrective and Preventive Action), Nonconforming Material Reports (NCMR), and Complaint processes.
• Perform internal audits and follow up on findings to ensure timely and effective closure of corrective actions.
• Facilitate root cause analysis, effectiveness verification, and trend analysis.

Training & Documentation

• Support QMS training programs and ensure employee understanding of quality system requirements.
• Oversee document control and record management systems.
• Participate in the evaluation of change control activities to ensure proper documentation and regulatory impact assessments.

Design Assurance

• Support product development projects, including assurance that design control requirements are met at all stages of a product’s development.
• Support risk management processes in accordance with ISO 14971.

Supplier Quality

• Perform supplier evaluations, including audits where appropriate and support supplier performance monitoring initiatives.

Training, Skills, Knowledge and/or Experience

• 8+ years of quality engineering experience in the medical device industry. Prior defense/aerospace industry experience & manufacturing engineering experience a plus.
• Fluent in ISO 13485, FDA 21 CFR Part 820, ISO 14971, and MDSAP requirements.
• Experience using electronic QMS tools (e.g., QCBD, MasterControl, Arena, etc.).
• Fluent in Microsoft Office 365 Suite (i.e. Word, Excel, PowerPoint, Access, Teams, SharePoint, etc.)
• Familiarity with ERP and PLM systems preferred

Competencies

• Project management and leadership skills, with proven experience leading and mentoring individuals across different levels and functions to investigate the root causes of internal and external audit findings and to implement effective and compliance corrective actions in a timely manner.
• Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to organize and prioritize multiple tasks and meet deadlines, with attention to detail and accuracy.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to analyze quality data, develop associated metrics, identify trends, and develop actionable reports in support of Management Reviews
• Strong organizational, interpersonal and presentation skills.

Supervisory Responsibility
None.
Educational Requirements 

• Bachelor’s degree in engineering or other technical field or an equivalent combination of education and work experience.
• Advanced degree or certifications (e.g., ASQ CQE, CQA, ISO 13485 Lead Auditor) preferred.

Working Conditions

• Office and controlled manufacturing environments, including manufacturing and engineering laboratory environments and ISO class 7 cleanrooms.  PPE required when in controlled environment rooms and cleanrooms.
• May require occasional travel (<10%) related to audit activities.

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