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Quality Assurance Director, Selution

3 months ago

Irvine, United States Cordis Full time

Overview:
MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

The Quality Director is responsible for providing leadership to maintain and improve all aspects of product, engineering, and process quality. Reporting to the VP of Quality, this role heads the following quality functions. Quality Systems, Quality Engineering & Quality Control, subsequently must maintain expertise in applicable Quality System and Regulatory requirements for the Company.

The Quality Director is also responsible to ensure the conformity to approved specifications, prior to release, of all finished products manufactured at the site.

The Quality Director plays a key strategic role in compliance, training and ensuring that adequate manufacturing quality plans are implemented, and that good practices are maintained at the site.

**Responsibilities**:

- Authorize the release for shipment of commercial and clinical products, based on conformity with established specifications and release criteria. Commercial products include:

- SELUTION SLR 018 PTA BALLOON CATHETER product line, on behalf of MASA.
- SELUTION SLR 014 PTCA BALLOON CATHETER product line, on behalf of MACV legal manufacturer representative
- Oversee all Quality Engineering and Quality Control resources, to ensure effective and successful achievement of the site level Quality Objectives and initiatives.
- Manage Q.C. processes from in-coming component inspection to final product release.
- Manage NCMRs and ensure meaningful metrics are reported.
- Site leadership for ensuring compliance with Quality System requirements defined in the Quality Manual and in support of FDA QSR’s, and ISO 13485:2016, MDR 2017/745, ISO 14971:2019 and other applicable standards and guidance documents.
- Manage the Internal Audit system, host external audits, and the coordinate follow-up actions.
- Manage the Master Plan to track scheduled QMS-related deliverables.
- Assuring product sterility by managing the microbiology functions and environmental monitoring, to ensure methods used for bioburden and sterilization monitoring are robust and compliant to the relevant ISO Standards (i.e., ISO 11137-xx).
- Q.E. support of the Qualification/Validation program in Ops and R&D to ensure Protocols and Test Reports, and the overall manufacturing process. meet standards and achieve the specified results.
- Participation on Design and Development teams to ensure quality plans are developed and deployed.
- Establishing and monitoring of Quality system and site Key Performance Indicators
- Contribute to the maintenance and improvement of the Quality Management System.
- Ensuring a risk-based approach is used to define or revise existing processes.
- Drive initiatives to achieve efficiency and improvement in Quality Control functionality.
- Management of the site CAPA program and chair of the CAPA Board.
- Responsible for the overall compliance at the site, and conformity of released products.
- Manage Resources to ensure an effective and efficient operation of Quality Control, systems and Quality Engineering based processes.
- Member of the Quality Management Team at the Irvine site
- Interacts with direct reports, suppliers, and other members of the local and global Management Team.

Qualifications:

- Bachelor's Degree in a Scientific or Engineering Discipline
- Experience with current medical device regulations in the EU, U.S, and Asia.
- 10+ years of experience in Class II or III Medical Device Quality Management
- 5+ years of experience in the validation and maintenance of CEAs.
- 5+ years of experience in team and project management.
- Strong Quality Assurance, Quality Engineering, and Class II/III medical device background.
- Proven Team Leader or Manager
- Confident personality with an ability to make independent, risk-based decisions.
- Certifications for Quality Engineering or Quality Auditor (preferred)
- Light office work and telecommute capability.
- Must be able to lift and carry up to 50 lbs.

Pay / Compensation

The expected pre-tax pay rate for this position is $169,400 - $242,550

Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

Why Join Cordis?

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disabil