Jobs
>
San Diego

    Quality Manager - San Diego, United States - IRRAS USA Inc.

    IRRAS USA Inc.
    IRRAS USA Inc. San Diego, United States

    3 weeks ago

    Default job background
    Manufacturing / Mechanical
    Description

    SUMMARY:

    The Quality Manager is a core member of the IRRAS Leadership Team and shall be accountable as the IRRAS Management Representative per ISO 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)

  • Simply Biotech

    Quality Manager

    1 week ago

    Simply Biotech San Diego, United States

    Quality Manager- Simply Biotech · OVERVIEW · Are you looking for a new career opportunity with an exciting biotech company? Then we've got the right team for you In this role, you're responsible for the duties listed below. · Immediate opening for a Quality Manager with a bi ...

  • Azzur Group

    Quality Manager

    2 days ago

    Azzur Group San Diego, United States

    Job Description · Job Description · Azzur COD is currently hiring for the position of Quality Manager to become a part of our exceptional team of proficient troubleshooters. The selected candidate will oversee the overall quality of Azzur GMP facilities at the designated locati ...

  • Johnson Service Group

    Quality Manager

    2 weeks ago

    Johnson Service Group San Diego, United States

    Job Description · Job Description Johnson Service Group, a nationally award-winning staffing firm, is looking to hire a Quality Manager for a privately held commercial medical device company in San Diego. · This role is Direct Hire | Onsite | Candidate must have authorization to ...

  • Azzur Group

    Quality Manager

    3 weeks ago

    Azzur Group San Diego, United States

    Job Description · Job DescriptionAzzur COD is currently hiring for the position of Quality Manager to become a part of our exceptional team of proficient troubleshooters. The selected candidate will oversee the overall quality of Azzur GMP facilities at the designated location. O ...

  • Lytx

    Quality Engineer Manager

    2 days ago

    Lytx San Diego, United States

    Why Lytx: · Lytx's hardware portfolio is growing at a rapid pace, both in the number of products and production volumes In order to support our growing business, we're looking for a Quality Engineer Manager to join our team You'll play a key role as Lytx scales, by driving conti ...

  • QuidelOrtho

    Manager, Quality Engineering

    1 week ago

    QuidelOrtho San Diego, United States

    The Opportunity · QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are m ...

  • ORIC Pharmaceuticals Inc

    Quality Assurance Manager

    3 weeks ago

    ORIC Pharmaceuticals Inc San Diego, United States

    · This position works in conjunction with other Quality team members and will manage day-to-day tactical quality operations related to GMP clinical manufacturing operations and clinical trial drug oversight activities. In addition, the role will support the Pharmaceutical Scienc ...

  • ASML

    Quality Supplier Manager

    5 days ago

    ASML San Diego, United States

    Introduction to the job · Are you our new Quality Supplier Manager, that will engage our suppliers to drive for Zero-Defects and the next level of Supplier Quality Performance? Do you combine an analytical mind-set with a hands-on approach? While making it happen, can you juggle ...

  • ORIC Pharmaceuticals Inc

    Quality Assurance Manager

    2 weeks ago

    ORIC Pharmaceuticals Inc San Diego, United States

    This position works in conjunction with other Quality team members and will manage day-to-day tactical quality operations related to GMP clinical manufacturing operations and clinical trial drug oversight activities. In addition, the role will support the Pharmaceutical Sciences ...

  • Aza

    Manager, Water Quality

    4 weeks ago

    Aza San Diego, United States

    SeaWorld California · Manager, Water Quality · At SeaWorld, we're passionate about caring for animals. In fact, we've already rescued over 40,000 animals (and counting). And we can save you from being stuck in just another job. Join us and help bring joy, excitement, and lasting ...

  • SeaWorld Parks

    Manager, Water Quality

    2 weeks ago

    SeaWorld Parks San Diego, United States

    At SeaWorld, we're passionate about caring for animals. In fact, we've already rescued over 40,000 animals (and counting). And we can save you from being stuck in just another job. Join us and help bring joy, excitement, and lasting memories to people from around the world. We're ...

  • Lennar

    Quality Assurance Manager

    2 days ago

    Lennar San Diego, United States

    Overview · Welcome Home Build your career with Lennar: · As one of the nation's largest builders, Lennar has built over one million new homes for families across America. Since 1954, our communities have catered to all lifestyles and family dynamics, whether you are a first-time ...

  • ASML US, LLC

    Quality Supplier Manager

    2 days ago

    ASML US, LLC San Diego, United States

    Introduction to the job · Are you our new Quality Supplier Manager, that will engage our suppliers to drive for Zero-Defects and the next level of Supplier Quality Performance? Do you combine an analytical mind-set with a hands-on approach? While making it happen, can you juggle ...

  • Lennar Homes

    Quality Assurance Manager

    2 days ago

    Lennar Homes San Diego, United States

    Overview: · Welcome Home Build your career with Lennar: · As one of the nations largest builders, Lennar has built over one million new homes for families across America. Since 1954, our communities have catered to all lifestyles and family dynamics, whether you are a first-tim ...

  • AppleOne

    Quality Assurance Manager

    3 days ago

    AppleOne San Diego, United States

    Job Description · Job DescriptionWe're looking for a Quality Manager to ensure our products meet top standards. You'll oversee quality management, process audits, customer interactions, and lead a team of six quality professionals. · Key responsibilities include conducting audits ...

  • BioPhase Solutions

    Quality Systems Manager

    2 weeks ago

    BioPhase Solutions San Diego, United States

    Job Description · Job DescriptionBioPhase specializes in recruiting top talented professionals for the San Diego County Scientific community. We are currently looking for a hybrid Manager of Quality Systems and Risk Management to work for a leading San Diego biotech company. · Pa ...

  • CalPortland

    Quality Control Manager

    2 days ago

    CalPortland San Diego, United States

    Press Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · Create Alert · Select how often (in days) to receive an alert: · The Quality Control Manager will assist the Quality Director with reviewing project specifications and recommending mix ...

  • Chugach Government Solutions, LLC

    quality control manager

    2 days ago

    Chugach Government Solutions, LLC San Diego, United States

    About Us · When you work at Chugach Government Solutions (CGS), you join a proud legacy of supporting missions while sustaining culture. · The federal division of Chugach Alaska Corporation, CGS has been supporting critical missions as a government contractor for over 25 years. ...

  • Chugach Government Solutions

    quality control manager

    2 weeks ago

    Chugach Government Solutions San Diego, United States

    About Us · When you work at Chugach Government Solutions (CGS), you join a proud legacy of supporting missions while sustaining culture. · The federal division of Chugach Alaska Corporation, CGS has been supporting critical missions as a government contractor for over 25 years. O ...

  • PowerFlex

    Manager - Safety & Quality

    1 week ago

    PowerFlex San Diego, United States

    Job Description · Job DescriptionScope of Job · The Manager, Safety & Quality will be responsible for the safe installation of PowerFlex projects across all technologies, at the national level. They will work closely with Execution leaders and project managers to keep our safety ...