Quality Systems Engineer

The Senior Quality Systems Engineer will ensure compliance with ISO 13485 and 21CFR 820 Quality System regulations. Oversee the Issues Management process including Corrective and Preventive Actions. Prepare quality metrics for management reviews and support data analysis with process owners. Actively participate in creating or improving QMS documentation, and ensuring solutions are implemented effectively. Lead internal audits, identifying non-conformances and areas for improvement as well as presenting the company to external auditors in a professional and knowledgeable manner. Ensure consistent change management and document control process execution and supporting peers. Lead Quality System software validation, support stakeholders with QS Enterprise software, and assist in evaluating and deploying new QMS software tools. Create and present professional training to cross-functional teams. Apply project management tools to complete tasks, identify obstacles, and ensure project milestones are met, while managing schedule risks. Support expansion of regulatory applications and regulation changes.

RESPONSIBILITIES:

· Identify opportunities for process improvement, lead continuous improvement initiatives, and implement changes to enhance product quality and efficiency.

· Global Issue Management and CAPA process owner, ensuring execution, accountability, and timeliness.

· Monitor and measure the effectiveness of the Quality System and drive continuous improvement through Management Review and other appropriate forums.

· Schedule and execute internal audit according to applicable regulations and standards.

· Host external audits in a professional and knowledgeable manner.

· Support Quality System software system validation, including scoping and implementing new software.

· Providing training to employees on quality policies, procedures, and best practices.

· Support expansion of regulatory applications to other geographies.

· Monitor regulation changes that affect the Quality System and ensure continued compliance.

· Follow all Nextern’s policies, practices and procedures to ensure that FDA and ISO regulations along with Nextern quality standards are met.

· Support QMS processes across all Nextern functions.

· Performs other related duties as assigned by management.

TECHNICAL COMPETENCIES:

• Regulations: Ensure compliance with ISO 13485 and 21CFR 820 QS; evaluate processes against regulations.
• Quality System Processes: Knowledgeable in QMS processes; actively improve documentation and ensure compliance with standards.
• Problem Solving: Proficient in problem-solving tools; collaborates to resolve complex issues and develop innovative solutions.
• Audit Support: Conducts audits and recommends improvements; identifies non-conformances and develops corrective action plans.
• Document Control Process: Advanced knowledge of change management and document control; ensures compliance during changes.
• Data Analysis: Prepares quality metrics for management reviews and supports data analysis efforts.
• Software: Leads QS software validation; supports deployment of new QMS tools.
• Training: Creates effective training materials and conducts presentations for global teams.
• Project Management: Utilizes PM tools to manage project schedules, identify risks, and drive project deliverables.
• Customer Interaction/Business Competency: Effectively communicates with customers and manages quality and business relationships.

LEADERSHIP COMPETENCIES:

• Communicating Effectively
• Change Management
• Collaborative Environment
• Operational Excellence
• Agile Decision Making
• Multiplier Leadership

EXPERIENCE / EDUCATION REQUIREMENTS:

• 8+ years in regulated manufacturing (medical device or pharmaceutical); ISO 13485 Lead Auditor certification preferred.
• Bachelor’s degree plus 4 years relevant experience, or minimum of 10 years in Quality Systems.
• Preferred: Agile PLM, Microsoft Power BI, Epicor ERP experience, and project management experience.

SUPERVISORY RESPONSIBILITIES: No supervisory responsibilities.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Passport required; able to travel internationally 1-2 times per year.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Training & Development
• Free Food & Snacks
• Wellness Resources