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Quality Systems Specialist
2 weeks ago
Johnson & Johnson is recruiting for a **Quality Systems Specialist **to be located in **Markham, Ontario, Canada **. **This position is a fixed-term role, expected to last 12 months.**
A Quality Systems Specialist is responsible for developing and maintaining quality control procedures and systems, ensuring compliance with industry standards and regulations. They design and implement quality assurance measures, conduct audits and inspections, and collaborate with cross-functional teams to implement corrective and preventive actions. They provide training and support, analyze data and generate reports on quality systems, monitor risk, and maintain documentation related to quality processes. They also participate in internal and external audits to ensure compliance with regulatory and customer requirements.
**Key Responsibilities**:
- Develop and maintain quality control procedures and systems to ensure compliance with industry standards and regulations.
- Provide Training development, implementation and oversight of our Learning Management System (LMS). Act as the regional Subject Matter Expert (SME) for Training and Qualification in global QMS meetings.
- Maintain documentation related to quality systems, including Standard Operating Procedures (SOPs) and work instructions. Act as the regional SME for Documentation Management in global QMS meetings.
- Responsible for leading all aspects of the Change Control processes. This includes evaluating proposed changes to assess their potential impact on quality systems, conducting risk assessments, and ensuring that appropriate change control procedures are followed. Act as the regional SME for Change Controls in global QMS meetings.
- Design and implement quality assurance measures/metrics to monitor and evaluate the effectiveness of existing processes.
- Conduct or participates in internal and external audits and inspections to identify areas for improvement and drive continuous quality improvement initiatives.
- Collaborate with cross-functional teams to develop and implement Corrective and Preventive Action Plans.
- Ownership of any identified Non-Conformances and investigate root cause and implement immediate corrections.
- Stay up-to-date on industry regulations and changes to ensure compliance and incorporate them into quality systems.
**Qualifications**:
**Education**:
- University/Bachelor's degree or equivalent in Science or Engineering required
**Experience and Skills**:
**Required**:
- 0 - 2 Years related experience working in a regulated industry, such as Medical Devices or Pharmaceuticals
**Preferred**:
- Familiarity working with quality management systems (i.e. TrackWise, ETQ, Windchill)
- Solid understanding of the Health Canada Medical Device Regulations and/or ISO 13485.
- Strong knowledge of quality control principles and practices.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and ability to prioritize tasks effectively.
- Effective communication and interpersonal skills to collaborate with different teams.
- 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._
