Sr. Quality Assurance Specialist

CooperSurgical; Ontario; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Sr. Quality Assurance Specialist to enhance quality processes and systems. This role involves managing quality oversight, engaging with stakeholders, and ensuring compliance with regulations. The ideal candidate will possess strong communication skills and a commitment to continuous improvement, along with a Bachelor's degree and relevant experience.

Benefits

Medical benefits

401(k)

Parental leave

Fertility benefits

Paid time off

Qualifications

• 6-8 years of experience in quality assurance or related field.
• Understanding of quality principles and current regulations.

Responsibilities

• Maintain a culture of quality awareness and teamwork.
• Manage Quality Management System Processes.
• Report Quality System metrics to support continuous improvement.

Skills

Communication

Integrity

Continuous Improvement

Education

Bachelor’s degree

Tools

Microsoft Office

Master Control

Job description

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Job Description

The Life Science Quality Assurance Specialist III is primarily responsible for establishing, developing, implementing, maintaining, and improving Quality System processes and programs. These include Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, Validations, and Product Transfer. The candidate will mentor and train new personnel on the Quality System(s). They will partner with stakeholders to enhance the quality program and culture within the organization. Strong communication skills, integrity, and a continuous improvement mindset are essential.

Responsibilities

• Maintain a culture of quality awareness, teamwork, and cooperation with Quality customers.
• Provide Quality oversight, support, and engagement as needed by Operations.
• Manage Quality Management System Processes such as :
• Document Control Program : review, approval, and maintenance of SOPs via electronic QMS, ensuring adherence to policies and templates.
• Change Management Program : review, approve, and track changes to procedures, software, processes, and equipment; facilitate investigations.
• Deviations and Nonconformances : review, approve, monitor events, and facilitate investigations and closure.
• Validations : review and approve equipment, systems, and design transfers.
• Quality Metrics : perform trending analysis, report indicators, and identify risks and improvements.
• Facilitate meetings, communicate status, and ensure closure of aging items.
• Gather performance metrics and coordinate management reviews.
• Report Quality System metrics to support continuous improvement and communicate risks.
• Work in teams to maintain cross-functional, cross-site process consistency.
• Create and implement training for QMS processes.
• Perform other QA duties as required.

Qualifications

Knowledge, Skills, and Abilities

• Understanding of quality principles and current regulations.
• Experience with statistics, documentation review, risk tools, technical writing, and investigations.

Computer Skills

• Knowledge of Master Control or similar eQMS is a plus.
• Proficiency in Microsoft Office applications.
• Adaptability, attention to detail, decision-making, initiative, interpersonal skills, results orientation, task management.
• Physical demands include sitting, talking, hearing, occasional standing, walking, and use of hands.

Education & Experience

• Bachelor’s degree or equivalent experience (6-8 years).
• Knowledge of relevant regulations (FDA, ISO, etc.).

Additional Information

We offer comprehensive benefits including medical, 401(k), parental leave, fertility benefits, paid time off, and more. Visit www.coopersurgical.com for details.

Equal employment opportunity statement and agency contact instructions are included.

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Quality Assurance Specialist • ON, Canada