Quality Systems Manager

3 weeks ago

Greater Sudbury, Canada Gentuity Full time

Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

• Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements).
• Manage Document Control system, including the Change Order process.
• Manage the CAPA, Complaints, SCAR, and Audit Findings processes.
• Lead supplier management, including maintaining the Approved Supplier List for Critical/Crucial Suppliers and facilitating the re-evaluation of suppliers, including review of supplier data as appropriate.
• Own the development of Quality Metrics, and coordinate quality data collection and analyses for use in Management Reviews.
• Lead for regulatory body audits.
• Manage the Internal and Supplier Audit processes.
• Lead Management Review and Quality Planning.
• Lead and manage site training program.
• Track and report on company Quality KPIs.
• Organize and lead monthly company meetings on established KPIs and Trends.
• Coach, counsel, and train direct reports. Monitor performance and take appropriate action as necessary.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Other projects and tasks as assigned.

EXPERIENCE/SKILL REQUIREMENTS:

Minimum of 7 years of experience in a Medical Device environment, 3-5 years supervisory experience. A working knowledge in the following areas:
• Internal and External auditing
• Corrective and Preventive action
• Excellent verbal, written and presentation skills
• Detailed organization skills
• Team player with excellent communication skills
• ISO 13485 and FDA Quality System Regulation
• Strong knowledge of Quality Systems programs including but not limited to Document Control, Record Control, Change Control, Training, and Device Master Record (DMR)
• Demonstrated experience in administration of electronic systems such as PLM, ERP, and MDM systems
• Strong communication skills, both written and oral; Ability to lead meetings and presentations
• Must be able to effectively communicate up/down and across different levels of the organization
• Demonstrated ability to work with MS Word, Teams, Excel, Project and Visio
• Demonstrated ability to independently troubleshoot issues with electronic systems
• Demonstrated experience in training users on systems and processes within an electronic environment
• Certified Internal Auditor preferred
• Lean and Six Sigma Green Belt Certified preferred

EDUCATIONAL REQUIREMENTS:

Bachelor’s with at least 8 years of experience. Or Master’s Degree with 6 years. Our 15+ years of experience may be considered in lieu of a degree for a candidate who can demonstrate the combination of experience, training, and education to be capable of successfully fulfilling all duties and responsibilities of the position.

#J-18808-Ljbffr

  • Quality Systems Manager

    1 week ago

    Greater Sudbury, Canada Gentuity Full time

    Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the...

  • Quality Systems Manager

    3 weeks ago

    Greater Sudbury Unitary Authority, ON, Canada Gentuity Full time

    Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the...

  • Quality Management Systems Manager

    3 weeks ago

    Greater Sudbury Unitary Authority, ON, Canada Gentuity Full time

    Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the...

  • Quality System Specialist

    1 month ago

    Greater Montreal Metropolitan Area, Canada St-Amour Full time

    We presently have a Quality System Manager with A CDMO; you will be integral in maintaining a comprehensive understanding of current Good Manufacturing Practices (GMP) and driving continuous improvement in performance and quality. Your role will involve ensuring compliance with regulatory requirements and industry standards in all GMP-related activities.You...

  • Contact Quality Assessor

    1 day ago

    Greater Sudbury, Canada Canadian Blood Services Full time

    **Job category**: Quality and regulatory affairs **Job posting ID**: 4348 **Employment status**:Regular full-time **Classification**:OPSEU 619 **Salary/Rate of pay**:$24.60 **Application deadline**: 2023-04-06 **Somewhere in Canada there’s a life you can save.** Be part of a dynamic, collaborative and caring organization committed to saving and...

  • Quality Assurance Developer

    5 days ago

    Greater Toronto Area, Canada Apex Systems Full time

    QA DeveloperClient: Top North American BankContract: 1 year rolling contractLocation: Toronto, Downtown Core (3 days a week in office)Project: Building/enhancing automation framework for new features of a large commercial banking web application on Selenium to test APIs, along with some SQL testing in a relational database environmentResponsibilities: Works...

  • Quality Assurance Developer

    5 days ago

    Greater Toronto Area, Canada Apex Systems Full time

    QA DeveloperClient: Top North American BankContract: 1 year rolling contractLocation: Toronto, Downtown Core (3 days a week in office)Project: Building/enhancing automation framework for new features of a large commercial banking web application on Selenium to test APIs, along with some SQL testing in a relational database environmentResponsibilities: Works...

  • Quality Manager

    5 days ago

    Greater Madawaska, Canada Futures Full time

    Location - CumbriaRole - Quality ManagerSalary - Circa £40kShift - 4 on 4 off (days)Here at Futures, we are delighted to be supporting aleading FMCG Manufacturing company based in the Cumbria area.Due, to recent growth the business is looking for an established Quality Manager to join the technical team and oversee the day to day running of the Quality...

  • Quality Assurance Developer

    7 days ago

    Greater Toronto Area, Canada Apex Systems Full time

    QA DeveloperClient: Top North American BankContract: 1 year rolling contractLocation: Toronto, Downtown Core (3 days a week in office)Project: Building/enhancing automation framework for new features of a large commercial banking web application on Selenium to test APIs, along with some SQL testing in a relational database environmentResponsibilities: Works...

  • Quality Assurance Developer

    5 days ago

    Greater Toronto Area, Canada Apex Systems Full time

    QA DeveloperClient: Top North American BankContract: 1 year rolling contractLocation: Toronto, Downtown Core (3 days a week in office)Project: Building/enhancing automation framework for new features of a large commercial banking web application on Selenium to test APIs, along with some SQL testing in a relational database environmentResponsibilities: Works...

  • Quality Assurance Developer

    6 days ago

    Greater Toronto Area, Canada Apex Systems Full time

    QA Developer Client: Top North American Bank Contract: 1 year rolling contract Location: Toronto, Downtown Core (3 days a week in office) Project: Building/enhancing automation framework for new features of a large commercial banking web application on Selenium to test APIs, along with some SQL testing in a relational database environment...

  • Quality and Risk Advisor

    16 hours ago

    Greater Sudbury, Canada Home and Community Care Support Services Full time

    Home and Community Care Support Services North East offers a wide-range of quality healthcare services and resources to support people of all ages at home, school or in community. In addition to planning, delivering and coordinating care for thousands of people each day in Northeastern Ontario, we also manage eligibility and admissions to long-term care...

  • Quality Improvement Consultant

    4 weeks ago

    Greater Sudbury, Canada Health Sciences North Full time

    **Quality Improvement Consultant**: Competition # 4002 Job Title Quality Improvement Consultant Department Organizational Excellence Status Temporary (Aug 2023 to Nov 2023) Work Type Full-time Affiliation Management Shift Assignment Days Bilingualism Required No Police Check Requirement N/A Site RLHC- Management Salary Information $46.22...

  • Enterprise Systems Analyst

    1 month ago

    Greater Sudbury, Canada Northern Ontario School of Medicine Full time

    Working collaboratively with the Senior Systems Analyst, this position will actively contribute to ensuring that systems align with academic and business requirements. The Enterprise Systems Analyst will maintain current knowledge of functional areas and industry ERP best practices and will take part in making recommendations for system modifications or...

  • Quality, Risk and Policies Coordinator

    1 day ago

    Greater Sudbury, Canada Home and Community Care Support Services Full time

    **Job Description**: Home and Community Care Support Services North East offers a wide-range of quality healthcare services and resources to support people of all ages at home, school or in community. In addition to planning, delivering and coordinating care for thousands of people each day in Northeastern Ontario, we also manage eligibility and admissions...

  • Manager, Quality

    4 weeks ago

    Greater Sudbury, Canada Canadian Mental Health Association Full time

    **WHY JOIN CMHA-S/M?!** As a nation-wide organization, the Canadian Mental Health Association (CMHA) promotes the mental health of all and supports the resilience and recovery of people experiencing mental illness. The CMHA accomplishes this mission through advocacy, education, research and service. **All Staff are Eligible for**: - Healthcare of Ontario...

  • Business Systems Consultant

    2 weeks ago

    Greater Toronto Area, Canada Apex Systems Full time

    Business Systems Consultant - Salesforce CRMApex Systems is a global IT services provider and our consulting practice has an opening for a Salesforce CRM Business Systems Analyst Consultant who will be responsible for delivering end-to-end project implementation and act as a subject matter expert in solutions on Salesforce’s Financial Services Cloud and...

  • Business Systems Consultant

    2 weeks ago

    Greater Toronto Area, Canada Apex Systems Full time

    Business Systems Consultant - Salesforce CRM Apex Systems is a global IT services provider and our consulting practice has an opening for a Salesforce CRM Business Systems Analyst Consultant who will be responsible for delivering end-to-end project implementation and act as a subject matter expert in solutions on Salesforce’s Financial Services Cloud...

  • Business Systems Consultant

    2 weeks ago

    Greater Toronto Area, Canada Apex Systems Full time

    Business Systems Consultant - Salesforce CRMApex Systems is a global IT services provider and our consulting practice has an opening for a Salesforce CRM Business Systems Analyst Consultant who will be responsible for delivering end-to-end project implementation and act as a subject matter expert in solutions on Salesforce’s Financial Services Cloud and...

  • Quality Control Coordinator

    4 weeks ago

    Greater Sudbury, Canada GDB Constructeurs Full time

    **Project and Quality Control Coordinator** **Specific Skills** Establish and implement policies and procedures for quality control. Implement and manage quality control programs. Establish and implement policies and procedures for environmental management programs. Implement and manage environmental programs. **Work Setting** Civil (road, dams and...