Quality Systems Manager
2 weeks ago
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
2 days ago
Greater Sudbury, Canada Gentuity Full timeGentuity 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
2 weeks ago
Greater Sudbury Unitary Authority, ON, Canada Gentuity Full timeGentuity 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
2 weeks ago
Greater Sudbury Unitary Authority, ON, Canada Gentuity Full timeGentuity 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
4 weeks ago
Greater Montreal Metropolitan Area, Canada St-Amour Full timeWe 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...
-
Quality System Specialist
4 weeks ago
Greater Montreal Metropolitan Area, Canada St-Amour Full timeWe 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...
-
Quality System Specialist
4 weeks ago
Greater Montreal Metropolitan Area, Canada St-Amour Full timeWe 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...
-
Quality System Specialist
3 weeks ago
Greater Montreal Metropolitan Area, Canada St-Amour Full timeWe 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...
-
Quality System Specialist
4 weeks ago
Greater Montreal Metropolitan Area, Canada St-Amour Full timeWe 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...
-
Lead, Business Systems
4 days ago
Greater Sudbury, Canada Vale Full time**Want to work with leading technology?** **Who We Are**: Welcome to Vale. Our purpose is to improve life and transform the future together. We value our workforce and strive to offer continuous training and career development opportunities for our people. Vale Base Metals is one of the world's largest producers of high-quality nickel and an important...
-
Data Quality Analyst
4 weeks ago
Greater Sudbury, Canada Health Sciences North Full time**Data Quality Analyst**: Competition # 3717 Job Title Data Quality Analyst Department Operating Room/Post Anesthetic Care Unit (OR/PACU) Status Permanent Work Type Full-time Affiliation Non Union Shift Assignment Days Bilingualism Required No Police Check Requirement N/A Site RLHC-Non Union Non Managment Salary Information $52,474.50 -...
-
Quality Coordinator
4 weeks ago
Greater Sudbury, Canada TESC Contracting Company Ltd Full time**Summary**: The Quality Coordinator is responsible to ensure optimum efficiency and compliance as set out in the site-specific Quality Management Plan, applicable codes, regulations, and client requirements. **Responsibilities** - Promote a culture of safety, high performance, and continuous improvement that values learning and a commitment to quality. -...
-
Commander Quality Improvement and Regulatory
4 weeks ago
Greater Sudbury, Canada City of Greater Sudbury Full time**Posting date**: February 23, 2023 **Job Title**: Commander Quality Improvement and Regulatory Compliance **Number of Vacancies**:1 **Posting number**: EX23-194 **Status**: Permanent Position **Hours of Work**: 70 hours bi-weekly **Shift Work Required**: No **Range of Pay**: $3,299.80 to $3,884.30 bi-weekly (Subject to Review) **Start date**: To...
-
Food Service Quality Assurance Associate
4 weeks ago
Greater Sudbury, Canada Health Sciences North Full time**Food Service Quality Assurance Associate**: Competition # 3681 Job Title Food Service Quality Assurance Associate Department Patient Food Services Status Permanent Work Type Full-time Affiliation CUPE Service Shift Assignment Days and evenings Bilingualism Required N/A Police Check Requirement N/A Site RLHC-Cupe Service Salary...
-
Food Service Quality Assurance Associate
4 weeks ago
Greater Sudbury, Canada Health Sciences North Full time**Food Service Quality Assurance Associate**: Competition # 3179 Job Title Food Service Quality Assurance Associate Department Patient Food Services Status Permanent Work Type Part-time Affiliation CUPE Service Shift Assignment Days and evenings Bilingualism Required N/A Police Check Requirement Vulnerable Sector Check Site RLHC-Cupe...
-
Quality Control Area Manager
4 weeks ago
Greater Sudbury, Canada Titan Building Services Full timeJoin the Titan Power Team! Cleaning is our Business. Is it yours? The Titan Power team takes great pride in keeping local businesses safe, sanitized and clean. We are growing and have an immediate need to add to our management team. We are seeking a _**QUALITY CONTROL AREA MANAGER **_for our locally owned janitorial company in the commercial and...
-
Business Systems Consultant
7 days ago
Greater Toronto Area, Canada Apex Systems Full timeBusiness 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
6 days ago
Greater Toronto Area, Canada Apex Systems Full timeBusiness 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
5 days ago
Greater Toronto Area, Canada Apex Systems Full timeBusiness 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...
-
Quality Assurance Specialist
4 weeks ago
Greater Sudbury, Canada Fuller Industrial Corporation Full time**Fuller Industrial Corporation**, a world supplier of carbon steel process piping systems, specializing in corrosion and abrasion resistant linings, rubber, and ceramic lining is recruiting for our Sudbury, Ontario Plant. This role supports our Sudbury operations by ensuring our quality processes are followed and documented to ensure we supply “on...
-
Systems Analyst
4 weeks ago
Greater Sudbury, Canada Health Sciences North Full time**Systems Analyst - Imaging and Medical System Integration**: Competition # 3316 Job Title Systems Analyst - Imaging and Medical System Integration Department IT Security and Infrastructure Status Permanent Work Type Full-time Affiliation Non Union Shift Assignment As assigned Bilingualism Required N/A ; Bilingualism is an Asset Police Check...