Sr. Analyst, Quality Systems

About the role

This role owns and advances key Quality Systems, including Training, Document Control, Change Control, Management Review, and Quality Audits, ensuring they are consistently implemented, compliant, and effective.

Responsibilities

• Own and continuously improve the site Quality Management System (QMS), ensuring alignment with regulatory requirements, ISO 13485 standards, and evolving business needs.
• Lead the implementation, administration, and ongoing effectiveness of Quality Systems, ensuring procedures, standards, and tools are consistently applied and optimized.
• Drive document control excellence by authoring, reviewing, and approving controlled documents to ensure accuracy, compliance, consistency, and timely periodic review.
• Maintain compliance readiness by coordinating internal and external audits, maintaining certifications, supporting regulatory requirements, and managing field actions.
• Lead Management Review processes, including compiling performance data, developing presentations, facilitating discussions, and driving closure of resulting action items.
• Own the Change Control process, conducting assessments, ensuring appropriate approvals, and driving timely execution and closure of changes.
• Develop, monitor, and communicate Quality System metrics, identifying trends, highlighting risks, and driving data-driven improvements.
• Interpret and communicate QMS KPIs, ensuring leadership has clear visibility into system performance and areas requiring action.
• Author, review, and continuously improve SOPs and controlled documents, ensuring alignment with corporate, divisional, site, and regulatory expectations.
• Lead and deliver Quality Systems training, serving as a subject matter expert to coach and mentor individuals and teams on regulatory expectations and best practices.
• Initiate and own nonconformance records (NCRs) as needed, supporting investigations to ensure robust root cause analysis and effective resolution.
• Plan and execute internal audits, and coordinate, host, and respond to external audits, ensuring the site maintains a constant state of inspection readiness.
• Drive cross-functional collaboration to resolve compliance gaps, supporting global and site initiatives and embedding sustainable improvements.
• Lead or contribute to multi-site Quality projects, ensuring alignment, execution, and successful delivery of shared objectives.
• Execute additional responsibilities and strategic initiatives as needed, supporting site and organizational priorities.
• Serve as a subject matter expert, coaching and mentoring individuals and teams on regulatory expectations and best practices.

Qualifications

• Demonstrates strong verbal and written communication skills, applying effective documentation practices and engaging confidently across all levels of the organization.
• Drives continuous improvement of procedures and processes, simplifying complexity, increasing efficiency, and enhancing usability across Quality Systems.
• Interprets and applies quality system regulations, ensuring compliance and translating regulatory requirements into practical, site-ready solutions.
• Maintains relevant professional certifications (e.g., CQA, ISO 13485 Auditor), or actively works toward certification to strengthen technical expertise.
• Fosters a collaborative, team-oriented environment, building strong relationships and influencing others through effective interpersonal and leadership skills.
• Applies strong problem-solving and critical-thinking skills, with a high level of attention to detail and the ability to clearly communicate findings and recommendations.
• Manages projects effectively, prioritizing work, meeting deadlines, and ensuring successful execution of multiple concurrent initiatives.
• Demonstrates working knowledge of FDA and ISO regulations, including ISO 13485 and 21 CFR 820, and ensures consistent application of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Education and/or Experience

• Bachelor’s degree in science or engineering or other related field.
• Minimum of 5+ years of experience in Quality with emphasis on regulation and compliance, or related field in the medical device industry.
• Audit experience (as auditee or auditor) required.

Physical Demands and Working Environment

• This is an onsite position and reliable attendance is needed to perform this role.
• Work typically related to an office environment such as frequent use of a keyboard, mouse, monitor.
• Occasional lifting up to 10 pounds.
• Frequent sitting or standing at a work station.
• Capable of gowning into an ISO 7/ISO 8 manufacturing environment.
• Noise is low to moderate as is typical in an office environment.
• Minimal travel up to 15% US.