MedRes International is looking for a Quality Director to join our team in our Carlsbad, CA office. The Quality Director will be responsible for deploying a quality system for Design, Development and in-house manufacturing of Class II and III devices at the Carlsbad facility. The Quality Director will lead and perform quality assurance activities in Carlsbad, working under FDA requirements, as a member of the global MedRes Quality team. The position reports to VP, Quality Assurance.

The Quality Director will have experience in developing quality systems, audit, and IQ, OQ, PQ, process validation. Activities will include developing, documenting, and maintaining technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with US & EU Medical Device regulations and other worldwide regulations.

Responsibilities include but not limited to:

· Develop and implement an electronic QMS.

· Support compliance to the following standards: ISO 13485, ISO 14971, FDA registered site.

· Experience with developing and maintaining quality management systems and manufacturing process control.

· Maintain design history file (DHF) and device master records (DMRs).

· Lead and provide direction and objectives for the Carlsbad engineering team ensuring processes within the QMS are maintained and improvements made.

· Ensure internal audits of the Quality Management Systems are carried out to maintain continued compliance with appropriate standards and regulations and make any recommendations for improvement.

· Support notified body audits and 3rd party audits and ensure all findings are followed up and closed out in a timely manner.

· Provide progress reports on Departmental KPIs and represent the Quality Department during Senior Management meetings in order to report status and recommend areas for improvement.

· Support new product development ensuring quality plans, specifications, training, and full validations are complete and ensure a smooth transfer to production.

· Manage non-conformances.

· Manage corrective and preventive actions (CAPAs) and lead CAPA teams as necessary.

· Manage supplier corrective action (SCARs) as necessary.

· Ensure validation of new materials, materials changes, equipment (IQ/OQ/PQ), environment/facilities, through full validation, training, and monitoring.

· Lead Continuous Improvement (CI) projects or assist with Continuous Improvement initiatives and communicate progress to CI teams with regards to key KPIs including waste and customer complaints.

· Manage change control and ensure the document control system is established and maintained.

· Establish supplier quality performance criteria and monitor supplier performance, including assessing supplier’s product specifications and approval of suppliers through site visitation and audit.

· Support the transfer of projects and products between the various MedRes sites.

· Support the development of a global MedRes quality team, including management responsibilities within this team.

Experience & Skills:

· Minimum of a Bachelor’s degree (Master degree desirable), preferably in engineering or technical discipline.

· CQE certification a plus.

· 10 years’ experience in quality system development and management with progressive and extensive experience in medical device quality assurance.

· Experience with Class II and Class III medical devices.

· Experience with ISO 8 certified cleanroom controlled environments.

· Experience in early-stage startup.

· Experience in all 5 phases of the product development lifecycle.

· Knowledge of project management best practices.

· Experience managing a comprehensive quality group that includes QA, QC, validation.

· Lead Auditor or trained as an internal auditor.

· Lean Six Sigma certification preferred.

· Excellent analytical and statistical skills.

· Excellent communications skills and a track record of accomplishment in leading and mentoring a subordinate team.

Compensation:

The estimated salary range for a new hire in this position is $175,000 to $200,000 depending on background and experience.