Our client is a medical device manufacturer of nursing beds they have been in this industry for over 100 years, The client has partnered with Randstad to support them on the search for their next Quality Manager role.
Position: Quality Manager | Metal Steel Fabrication
Location - Beamsville (10 mins from Grimsby and 18 mins from St Catherine)
...
Industry -Medical Nursing beds
Salary - Depends on experience.
Reports to - Director of Quality
This position is responsible for maintaining effective Quality Systems in accordance with Health Canada, and FDA Quality Systems Regulations. The Quality Manager works with engineering and manufacturing personnel to develop specifications, processes, and procedures that will ensure our products meet or exceed our customers’ expectations.
If you are interested in this opportunity send your resume directly to Mina Khalil at mina.khalil@randstad.ca
Advantages
There are a few benefits to working with this organization, Company Paid benefits, Bonus, Great team environment and paid vacation.
Responsibilities
Continuous improvement should be an output from the constant QMS PDCA feedback loop. Leads the Quality Specialists, Quality Technicians, and Quality Engineers in daily activities to support the above functions. The role of the Quality Manager is to champion all major components of the QMS including change control, process control, calibration, and CAPA through feedback.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Develop, implement, maintain and monitor quality metrics for the facility.
• Document quality systems and programs in quality trends, training, corrective and preventive actions, process control, customer complaints, etc. to ensure compliance with FDA, Health Canada, applicable ISO standards, and regulatory requirements.
• Ensure corrective actions implemented are effective by verifying that repeat failures are eliminated.
• Lead regulatory inspections and customer audits.
• Support the Internal Audit Program by participating in internal audits per the schedule and review the results of all audits to ensure the resolution of any noted deviations.
• Implement inspection/audit programs in manufacturing.
• Help ensure proper coordination and cooperation with supporting departments and regulatory bodies.
• Assist with employee development, coaching and performance management, as needed.
• Additional duties as requested or required.
ACCOUNTABILITIES:
• Interface with product development, manufacturing, process, and quality personnel
• Integral part of the ECO process (regulatory requirements, process capability/control, quality plans, etc).
• Establish Process Control Plans and ensure conformance to regulatory requirements.
• Provide all necessary information concerning product parameters and inspection to production personnel.
• Set up proper instrumentation to measure and record variables and train employees on the proper use of the instruments.
• Evaluate processes and ensure they are capable of consistently meeting specification requirements
• Define attributes and set accept/reject parameters
• Assist in developing effective corrective actions to quality issues
• Assist with returned product investigations as needed to understand failure modes and actions required.
• Assist with handling customer complaints and service requests.
• Willing to travel to customers to resolve quality problems and build effective customer relationships.
• Develop and implement quality control standards and inspection procedures for receipt and control of
incoming materials, in-process materials, final product acceptance activities and non-conforming materials.
• Establish and maintain test instrument calibration procedures and maintenance schedules.
• Active participant in all stages of design development, ensuring quality assurance considerations and requirements met.
• Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation.
• Participate in the review of product requirements, design requirements, and software requirements specifications, and functional specifications
Qualifications
Qualifications, Skills and Abilities:
• Minimum BSc, Quality, Engineering or Mechatronics education or equivalent work experience required.
• Five to ten years of experience in Quality Assurance/Compliance, preferably in a managerial role.
• Experience in medical device manufacturing, steel manufacturing, automotive or aeronautics industries
preferred.
• Thorough knowledge of CGMP/FDA regulations, an asset.
• Experience with Regulatory Agencies Internal /Externals Audits programs.
• Very strong documentation management skills.
• Knowledge in the interpretation of engineering drawings, specifications and manufacturing process
evaluation.
• Strong computer knowledge (Word, Outlook, Excel, PP).
• Excellent writing, communication, and presentation skills.
• Ability to work autonomously with sense of urgency.
Summary
If you are interested in this opportunity send your resume directly to Mina Khalil at mina.khalil@randstad.ca
Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada. As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees. In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.
Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle. We ask that all job applications please identify any accommodation requirements by sending an email to accessibility@randstad.ca to ensure their ability to fully participate in the interview process.
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Our client is a medical device manufacturer of nursing beds they have been in this industry for over 100 years, The client has partnered with Randstad to support them on the search for their next Quality Manager role.
Position: Quality Manager | Metal Steel Fabrication
Location - Beamsville (10 mins from Grimsby and 18 mins from St Catherine)
Industry -Medical Nursing beds
Salary - Depends on experience.
Reports to - Director of Quality
This position is responsible for maintaining effective Quality Systems in accordance with Health Canada, and FDA Quality Systems Regulations. The Quality Manager works with engineering and manufacturing personnel to develop specifications, processes, and procedures that will ensure our products meet or exceed our customers’ expectations.
If you are interested in this opportunity send your resume directly to Mina Khalil at mina.khalil@randstad.ca
Advantages
There are a few benefits to working with this organization, Company Paid benefits, Bonus, Great team environment and paid vacation.
Responsibilities
...
Continuous improvement should be an output from the constant QMS PDCA feedback loop. Leads the Quality Specialists, Quality Technicians, and Quality Engineers in daily activities to support the above functions. The role of the Quality Manager is to champion all major components of the QMS including change control, process control, calibration, and CAPA through feedback.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Develop, implement, maintain and monitor quality metrics for the facility.
• Document quality systems and programs in quality trends, training, corrective and preventive actions, process control, customer complaints, etc. to ensure compliance with FDA, Health Canada, applicable ISO standards, and regulatory requirements.
• Ensure corrective actions implemented are effective by verifying that repeat failures are eliminated.
• Lead regulatory inspections and customer audits.
• Support the Internal Audit Program by participating in internal audits per the schedule and review the results of all audits to ensure the resolution of any noted deviations.
• Implement inspection/audit programs in manufacturing.
• Help ensure proper coordination and cooperation with supporting departments and regulatory bodies.
• Assist with employee development, coaching and performance management, as needed.
• Additional duties as requested or required.
ACCOUNTABILITIES:
• Interface with product development, manufacturing, process, and quality personnel
• Integral part of the ECO process (regulatory requirements, process capability/control, quality plans, etc).
• Establish Process Control Plans and ensure conformance to regulatory requirements.
• Provide all necessary information concerning product parameters and inspection to production personnel.
• Set up proper instrumentation to measure and record variables and train employees on the proper use of the instruments.
• Evaluate processes and ensure they are capable of consistently meeting specification requirements
• Define attributes and set accept/reject parameters
• Assist in developing effective corrective actions to quality issues
• Assist with returned product investigations as needed to understand failure modes and actions required.
• Assist with handling customer complaints and service requests.
• Willing to travel to customers to resolve quality problems and build effective customer relationships.
• Develop and implement quality control standards and inspection procedures for receipt and control of
incoming materials, in-process materials, final product acceptance activities and non-conforming materials.
• Establish and maintain test instrument calibration procedures and maintenance schedules.
• Active participant in all stages of design development, ensuring quality assurance considerations and requirements met.
• Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation.
• Participate in the review of product requirements, design requirements, and software requirements specifications, and functional specifications
Qualifications
Qualifications, Skills and Abilities:
• Minimum BSc, Quality, Engineering or Mechatronics education or equivalent work experience required.
• Five to ten years of experience in Quality Assurance/Compliance, preferably in a managerial role.
• Experience in medical device manufacturing, steel manufacturing, automotive or aeronautics industries
preferred.
• Thorough knowledge of CGMP/FDA regulations, an asset.
• Experience with Regulatory Agencies Internal /Externals Audits programs.
• Very strong documentation management skills.
• Knowledge in the interpretation of engineering drawings, specifications and manufacturing process
evaluation.
• Strong computer knowledge (Word, Outlook, Excel, PP).
• Excellent writing, communication, and presentation skills.
• Ability to work autonomously with sense of urgency.
Summary
If you are interested in this opportunity send your resume directly to Mina Khalil at mina.khalil@randstad.ca
Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada. As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees. In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.
Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle. We ask that all job applications please identify any accommodation requirements by sending an email to accessibility@randstad.ca to ensure their ability to fully participate in the interview process.
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