Senior Quality Systems Specialist
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Job Location:
Monthly Salary:
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality SystemsJob Category:
ProfessionalAll Job Posting Locations:
Markham Ontario CanadaJob Description:
Johnson & Johnson is currently recruiting for Senior Quality Systems Specialist! This position will be located in Markham Ontario. This is a 12 month duration based role.
Role Summary:
This position will be responsible for support and maintenance of the Quality System and Compliance within the requirements of Health Canada and J&J Corporate Standards.
This position has primary responsibility for supporting shaping monitoring and assessing of key Quality System process and quality system architecture to maintain continuous compliance with Health Canada regulations while balancing and continuously improving the customer experience.
Primary functions include compliance with appropriate processes/controls for Quality System related activities including but not limited to: change management and change controls document management metrics management review Non-conformance/CAPA Supplier management and Field Actions.
Major Responsibilities:
Supports and executes key strategies necessary to deliver on JJMT Commercial Qualitys compliance.
Shapes implements and continuously improves JJMTs Quality Systems and Quality Compliance to ensure delivery against the strategies and measures.
Ensure quality systems are in compliance with J&J Standards and regulatory requirements in critical areas including but not limited to: supplier management non-conformance management change management document/records management training.
Provide subject matter expertise to project teams; escalate quality and compliance risks to management and project governance as required.
Supports quality deliverables on projects and ensures project timelines are met.
Supports cross-functional coordination with cross-functional teams: RA Commercial Supply Chain etc.
Other duties as assigned
Job Knowledge Requirements:
Relevant knowledge and experience
BSc or equivalent in Life Sciences or related field post graduate program in Quality is an asset.
Minimum 2 to 4 years of experience working in a regulated environment.
Experience required in a device Quality/Regulatory environment.
Strong knowledge of device Quality Management Systems.
Knowledge of GMPs GDPs Quality Systems Canadian Drug and Medical Device Regulations.
Experience across the elements of a quality organization quality systems (CAPAs NCs Change Controls) quality operations and regulatory compliance.
Technical competency requirements:
Strong knowledge of Canadian regulations: Medical Device Regulations Food & Drug Act GMPs.
Ability to work with ambiguity and in a complex/rapidly changing environment and make the complex simple for others to understand.
Other duties as assigned
Ability to build and nurture strong positive relationships with business leadership and partners including Regulatory Affairs Commercial Quality partners Source companies and third-party service providers.
Ability to work in a matrix environment with multiple stakeholders and priorities.
Detail-oriented with a big picture risk-based approach; able to apply risk management to decisions and process design.
Ability to identify risks and propose mitigation strategies
Results-oriented proactive and comfortable working independently with minimal supervision
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
