Sr Quality Manager

Spinologics is looking for a Sr QA Manager – Quality Assurance:

 

COMPANY DESCRIPTION

Spinologics mission is the improvement and development of new technologies for the treatment of pathologies of the spine. Our team, a group of innovative surgeons and engineers, is constantly working to advance and innovate current surgical devices and techniques. Spinologics was founded with the main principle of using rigorous research and development methods to bring the best products to the market.

 

Spinologics arrived at a pivotal moment of its young existence. We have several important opportunities for major developments in our area of ​​expertise including the development of a system to treat scoliosis in young patients.

 

JOB DESCRIPTION

Reporting to the CTO, the Sr QA Manager – Quality Assurance is responsible for establishing and maintaining compliance of Quality Systems Regulations, ISO 13485 and the Medical Device Directive.

 

PRINCIPAL RESPONSIBILITIES

  • Oversee the implementation of the quality system procedures and requirements, including regulatory requirements and ensure compliance is adhered to and training documented.
  • Work closely with the development team: test results, continuous improvements and system requirements.
  • Lead and maintain production controls.
  • Work with engineers to assure proper risk management and design controls.
  • Certification of suppliers and manage supplier quality documentation, visits to suppliers for audits.
  • Support regulatory filings with notified bodies and FDA.
  • Assure audit readiness at all times. Support compliance audits, propose corrections, corrective actions, preventive actions, and perform effectiveness verifications as required.
  • Manage CAPA activities and customer complaints.
  • Participate in design reviews.
  • Participate in risk management activities that involve the development and maintenance of the risk management file and assure sustained compliance with procedures, regulations and standards.

REQUIRED PROFILE

  • Bachelors or Master’s Degree in Engineering
  • Minimum of 8 years’ experience in a medical device environment implementing quality systems
  • Experience in MEDICAL Manufacturing REQUIRED
  • Audit preparation experience is required
  • FDA Title 21 CFR 820 experience is required
  • Demonstrated knowledge of quality systems and ability to sustain a strong QMS
  • Experience with Quality requirements and the required documentation
  • Experience working with customers resolving quality issues

We invite interested candidates to send us their resume to the attention of Sophie Lemieux: slemieux@spinologics.com