Senior Quality Systems Specialist
Location
Markham, ON | Canada
Job description
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Description Johnson & Johnson is recruiting for a Senior Quality System Specialist to be located in Markham, Ontario, Canada. Remote work options may be considered on a case-by-case basis and if approved by the Company. This is position is a duration based role of 12 months.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at
The Senior Quality Systems Specialist is responsible for ensuring adherence to quality standards and regulatory requirements within an organization. Leads all aspects of the establishment and maintenance of quality management systems, develop and implement quality policies and procedures, and conduct audits to measure compliance. Also, identify areas for improvement, analyze data to identify trends, and provide mentorship in resolving quality-related issues. Additionally, the successful candidate may lead or support cross-functional teams in implementing quality initiatives and driving continuous improvement. Strong knowledge of quality management principles and regulations, as well as excellent analytical and problem-solving skills, are crucial for this role. This role is specifically dedicated to the project that will implement the new Quality System for our Escalation, Field Action & Recall processes. The organization will be transitioning out of its current system, TrackWise, and into our new system, EtQ Instinct. As such, experiences in both TrackWise and EtQ Instinct is an asset.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
Key Responsibilities: - Responsible for the drafting and execution of Change Controls/Quality Plan related to the project.
- Responsible for procedure revisions and tracking to ensure procedures are approved and released by target dates as set out in the project timelines.
- Responsible for monitoring open records (through Qlik reports) to resolve whether records can be closed prior to migration.
- Responsible for migration of all open records from TrackWise into EtQ Instinct.
- Responsible for completing and performing testing (Business Simulation Testing and User Acceptance Testing) in EtQ Instinct Pre-Production environments.
- Develop, implement, and maintain quality management systems, protocols, and procedures in accordance with industry standards and regulatory requirements.
- Conduct comprehensive audits and assessments of internal processes, identifying areas for improvement and recommending corrective actions.
- Collaborate with cross-functional teams to establish and monitor key performance indicators to measure the efficiency of quality systems.
- Lead investigations into any non-conformances or quality incidents, using root cause analysis techniques to establish appropriate corrective and preventive actions.
- Ensure all documentation and records related to quality systems are accurately maintained and readily accessible.
- Provide mentorship and advice to colleagues on quality standards and best practices, conducting training sessions when vital.
- Stay up-to-date with industry trends and changes in regulatory requirements, adapting quality systems accordingly.
- Act as the subject matter authority during regulatory inspections, audits, and customer visits.
- Collaborate with suppliers and vendors to ensure effective quality control and compliance throughout the supply chain.
- Continually seek opportunities to optimize processes, promote a culture of continuous improvement, and improve overall quality performance.
Qualifications Education:
- A minimum of a Bachelor's degree is required. Focus degree in Engineering field is preferred.
Experience and Skills: Required:
- A minimum of 2 years of related work experience.
- Experience in a relevant scientific or engineering field.
- Proven experience in a quality management role within a regulated industry (medical devices, pharmaceuticals, etc.).
Preferred: - Solid understanding of quality management systems such as ISO 9001, ISO 13485, Health Canada Medical Device regulations, EUMDR regulations and/or FDA regulations.
- Validated experience with risk management methodologies (e.g., FMEA, HACCP) and statistical analysis techniques.
- Excellent understanding of root cause analysis, corrective and preventive action (CAPA), and change control processes.
- Strong analytical and problem-solving skills, with the ability to think strategically and get results.
- Outstanding attention to detail and accuracy in documentation and record-keeping.
- Effective communication and interpersonal skills, with the ability to collaborate with team members at all levels of the organization.
- Experience in leading and managing cross-functional teams.
- Experience with conducting audits, including internal audits, supplier audits, and regulatory inspections.
- Understanding of document control practices and experience managing documentation systems.
- Competence in data analysis and interpretation, including the ability to use relevant software tools.
- Knowledge of validation processes, including equipment qualification, process validation, and software validation.
- Familiarity with quality tools and methodologies, such as Six Sigma or Lean.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.
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