Sr. Quality Assurance Specialist

CooperSurgical; Ontario; On-site; CAD 60,000 - 95,000; Full time

Job summary

Ein etabliertes Unternehmen in der Life-Science-Branche sucht einen erfahrenen Qualitätsmanagement-Spezialisten, um die Qualitätssysteme zu etablieren und zu verbessern. In dieser spannenden Rolle sind Sie verantwortlich für die Überwachung von Qualitätsereignissen, die Schulung neuer Mitarbeiter und die Förderung einer Kultur der kontinuierlichen Verbesserung. Sie arbeiten eng mit verschiedenen Abteilungen zusammen, um sicherzustellen, dass alle Qualitätsstandards eingehalten werden. Wenn Sie eine Leidenschaft für Qualität und eine proaktive Einstellung haben, ist dies die perfekte Gelegenheit für Sie, um einen bedeutenden Einfluss zu erzielen.

Benefits

Medizinische Leistungen

401(k)

Elternzeit

Fertilitätsleistungen

Bezahlter Urlaub

Qualifications

• Verständnis der Qualitätsprinzipien und aktuellen Vorschriften.
• Erfahrung in der Dokumentenprüfung und technischen Schreiben.

Responsibilities

• Wartung des Qualitätsmanagementsystems und Unterstützung der Betriebsabläufe.
• Überwachung von Abweichungen und Nonkonformitäten sowie Durchführung von Schulungen.

Skills

Qualitätsmanagement

Dokumentenprüfung

Technisches Schreiben

Risikomanagement

Statistik

Education

Bachelor-Abschluss

6-8 Jahre relevante Erfahrung

Tools

Master Control eQMS

Microsoft Office

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

1. Maintain a culture of quality awareness, teamwork, and cooperation with Quality customers.
2. Provide Quality oversight, support, and engagement as needed by Operations.
3. 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.

1. Facilitate meetings, communicate status, and ensure closure of aging items.
2. Gather performance metrics and coordinate management reviews.
3. Report Quality System metrics to support continuous improvement and communicate risks.
4. Work in teams to maintain cross-functional, cross-site process consistency.
5. Create and implement training for QMS processes.
6. 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.

Additional Competencies

• Adaptability, attention to detail, decision-making, initiative, interpersonal skills, results orientation, task management.

Work Environment

• 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.