Sr Quality Systems Engineer

stratasys•Hopkins, MN

4d•$110,000 - $125,000•Remote

About The Position

The Sr Quality Systems Engineer will assist in an organizational Quality transformation to support customer requirements for manufacturing readiness. In this role the Quality Engineer is responsible for developing and implementing quality standards, procedures, and processes that meet customer expectations and regulatory requirements. Lead and ensure requirements are communicated and understood across the organization and continuously improve through creating value to customers and business processes aimed at meeting or exceeding customer expectations, improving quality, identifying efficiencies, and reducing total cost. Conduct internal assessments and oversight activities and work with various functions to address QMS-related concerns or compliance with new initiatives.

Requirements

Must be Export Control Compliant (ITAR)
Solid knowledge of ISO9001 with (at a minimum) exposure and understanding of AS9100
5 years’ experience in a manufacturing environment working in a quality assurance organization, using data to make decisions,
Understanding and proven practices of Lean methodologies and green belt in Six Sigma
Excellent statistical/analytical skills for problem-solving with the ability to teach/coach others and knowledge of SPC (Statistical Process Control) techniques.
Must understand and be able to apply the elements of corrective and preventive actions, including root cause analysis, failure mode, and effects analysis (FMEA), and the control of nonconforming material.
Good engineering practices including documentation, engineering change control, reporting, and cost/benefit analysis.

Nice To Haves

Knowledge of Counterfeit Program requirements.
Project Management Certification (ex PMP)
Certified Quality Engineer and/or Certified Quality Auditor,, ASQ certification
Knowledge of ISO13485 and/or FDA Quality Management System Regulation.
Knowledge of EU Medical Device Regulation (MDR), FDA QMSR

Responsibilities

Lead the development and/or improvement of companywide programs and systems to support the companywide quality transformation (Ex. counterfeit prevention program, QMS certifications, business continuity planning, RCCA, risk-based thinking, data-driven decision making, industry best practices, etc.).
Work with cross functional teams to assess, develop, and implement customer driven specification compliance.
Serve as the SME (Subject Matter Expert) in RCCA and CAPAs; Train, coach, and mentor the organization to drive growth and ensure sustainability in this and other core competencies.
Stay updated on industry’s best practices, emerging quality trends, and regulatory changes to drive continuous improvement in quality systems and processes.
Perform quality system, process, product audits, and surveys to ensure business requirements including flow down and quality standards are met.
Ensure compliance with relevant regulatory standards, such as ISO9001, AS9100, or ISO13485, and other industry-specific requirements.
Oversee scheduling, coordination, and execution of internal and external quality system audits.
Lead risk management activities: Including the development and implementation of FMEAs, process control plans, and quality agreements.
Develop, optimize, sustain metrics and oversee the ongoing management of QMS processes to ensure compliance, suitability, and health of processes.
Utilize statistical techniques and six sigma tools, analyzing processes, and driving continuous improvement activities.
Support in the development, approval and execution of process validation protocols and reports for critical processes.
Analyze quality data and metrics to identify trends, patterns, and areas for improvement. Present findings and recommendations to management and stakeholders.