Elliquence

• Manage the QMS structure, ensuring all policies, procedures, and Work Instructions (SOPs) are compliant with regulatory requirements and align with company strategic goals.

• With guidance from the Quality Affairs Director, lead both internal and external audits (customer, registrar, regulatory), coordinate audit finding responses, and verify the effectiveness of corrective actions.

• Lead root cause analysis (RCA) for non-conformances, customer complaints, and deviations, implementing effective Corrective and Preventive Actions (CAPA).

• Drive continuous improvement initiatives using lean methodologies, SPC (Statistical Process Control), and data analysis to enhance operational efficiency.

• Manage the electronic Quality Management Systems (eQMS) and ensure Document Control processes are current, accurate, and compliant.

• Confirms alignment of all Quality programs within the organization.

• Monitor and ensure the organization’s commitment to quality meets or exceeds customer requirements and the relevant regulatory standards.

• Develop, trend, and report key QMS performance metrics (KPIs) to senior management and provide solutions to guide data-driven decision-making.

• Develop training materials and educate staff on QMS procedures, GMP (Good Manufacturing Practices), or regulatory compliance to cultivate a culture of quality. 

• Consistently review SOP and other services to improve quality and contain costs.

• Minimum of 5 years of experience in a leading role in Quality Management Systems or Quality Assurance in the medical device industry required (spine or neuro device companies a plus).
• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field. Master’s degree will be considered for 1 year work experience in related QMS field in medical device industry (preferably spine or neuro).
• Strong knowledge of ISO 9001, ISO 13485, or AS9100:2016 standards.
• Leadership ability in root cause analysis tools, Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), and electronic QMS software.
• Certified Internal Auditor (ISO 9001/13485) preferred. 
• Lean Six Sigma Certifications preferred (Black Belt and/or Green Belt)

• Excellent written and verbal communication skills for interfacing customers and regulators.
• Proven ability to partner and influence cross-functional teams, lead/mentor through collaboration and influence without direct authority.
• Strong analytical abilities to interpret data and implement effective, sustainable solutions.
• Proficient in problem solving with independent thought and judgement while using resources both internally and externally.
• Work efficiently and proactively cross functionally in a team setting while being sensitive to deadlines.
• High level of accuracy in document review and compliance assessment. 
• Successful record of ability to work both independently and in a team environment.
• Skilled in statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis for data-driven decision-making.
• Determined and proactive mindset who is motivated to make a difference with a high standard of excellence.

• ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
• Experience in a heavily regulated industry (Medical Device or Pharma).
• Administration experience for document control.

An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.

We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.

We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [email protected].