Quality Manager

SUMMARY:

The Quality Manager is a core member of the IRRAS Leadership Team and shall be accountable as the IRRAS Management Representative per ISO 13485. This individual will serve as the Quality Subject Matter Expert (SME) and routinely report to Executive Management on the QMS health and compliance status. This position requires a “hands-on” working manager who thrives on making daily impact and effectively collaborates with their colleagues. The essential responsibility of this role is to assure local & global compliance of the IRRAS Quality Management System (QMS) to all applicable regulatory standards and device & site registrations. As a core competency, the candidate will have a track record of and expertise in leading and developing a team while simultaneously living our culture core values.

The ideal candidate will have a deep understanding of the medical device industry as it pertains to managing and improving a medical device QMS. This person will own the QMS throughout the product life cycle, during agency audits, and the assure the IRRAS Class I measure & sterile, Class IIb electro-mechanical and sterile, and Class III sterile medical devices are held to the highest quality standards.

ESSENTIAL FUNCTIONS:

Demonstrate the behaviors which emulate our core values.

Be the IRRAS Management Representative per ISO 13485 to ensure the suitability, adequacy, appropriateness, and compliance of the IRRAS QMS to all applicable governance and standards.

Mentor and grow the Quality Staff.

Oversee all QMS activities, e.g., Training, Customer feedback & complaint management, Deviations, non-conformances, quarantine materials, Corrective and Preventive Actions (CAPAs), Supplier quality, Supplier Corrective Action Reports (SCARs), Change Control, Preventative Maintenance and Calibration, Product Recalls, QMS administration, etc.

Mindfully and judiciously adhere to the Quality budget.

Provide sound quality assurance judgement and assessments.

Continuously improve the QMS to remain in alignment with the ever-evolving business needs.

Set and facilitate accomplishment of the Company Quality Objectives.

Demonstrate leadership, poise, and swagger when hosting audits from the CA Department of Public Health, FDA, the IRRAS Notified Body, and other governing agencies.

Assure risk management activities and reports comply with ISO 14971.

Drive and broadly communicate QMS and device quality actions based on trended actionable data derived from internal manufacturing results, customer feedback, and device field performance.

Leadership over all internal, external, and supplier audit activities.

Oversight of quality plans.

Manage the review, inspection, and approval of components and finished good products manufactured for and by the Company in accordance with their approved specifications

May perform additional duties as assigned or directed by management

EDUCATION/EXPERIENCE REQUIRED:

Bachelor's degree in life science or related field or the equivalent combination of education and experience. Engineering or scientific degree preferred.

7+ years quality experience in medical device, IVD, or biotech companies

3+ years in a successful leadership and direct line management role

Demonstrated competency complying with all QMS related governance and standards

Ability to be effective in a small to medium size early-stage commercial business

KEY QMS GOVERNANCE and STANDARDS:

21 CFR Part 820 – Quality System Regulation & ISO 13485 – Quality Management

European Medical Device Directive (MDD) 93/43/EEC & Medical Device Regulation (MDR) 2017/745

Medical Device Single Audit Program (MDSAP)

ISO 14971 – Application of risk management to medical devices

Current Good Manufacturing Practice (cGDP) and Good Documentation Practice (GMP)

Sort, Set in Order, Shine, Standardize, and Sustain (5S)