CQ Specialist

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DePuy Synthes is recruiting for a(n) CQ Specialist located in Toronto Ontario Canada.

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Overview

The CQ Specialist supports the execution and maintenance of Quality and Compliance activities across DePuy Synthes orthopedic portfolio. This role plays a key part in ensuring products processes and systems meet internal requirements and external regulatory standards. The CQ Specialist partners crossfunctionally to drive compliance support continuous improvement and help safeguard patient safety while enabling business performance. This is an excellent opportunity to build deep expertise in medical device quality systems within a global innovationdriven organization.

Key Responsibilities

• Support implementation and ongoing maintenance of Quality Management System (QMS) processes in alignment with global and regional requirements.
• Execute and track quality and compliance activities including documentation review record management and metrics reporting.
• Participate in internal audits inspections and assessments; support preparation execution and followup activities.
• Support investigation documentation and closure of quality events including deviations nonconformances and CAPAs.
• Collaborate with crossfunctional partners (Manufacturing Engineering Regulatory Supply Chain) to ensure compliance with applicable standards and procedures.
• Maintain accurate and timely quality records in designated systems and repositories.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance quality processes and controls.
• Support training activities related to quality and compliance requirements as applicable.

Qualifications

Education

• Bachelors degree required in Science Engineering Quality or a related discipline.
• Advanced degree in a related field preferred.

Experience and Skills

Required:

• Approximately 24 years of experience in Quality Compliance or a regulated environment preferably within medical devices pharmaceuticals or life sciences.
• Working knowledge of quality systems and compliance principles (e.g. QMS documentation controls CAPA).
• Strong attention to detail with the ability to manage and review technical documentation accurately.
• Ability to follow established procedures while exercising sound judgment within defined guidelines.
• Proficiency with standard business systems and quality databases.

Preferred:

• Experience supporting audits or inspections in a regulated environment.
• Familiarity with medical device regulations and standards (e.g. ISO 13485 FDA QSR).
• Experience working in a global or matrixed organization.
• Demonstrated ability to support continuous improvement initiatives.
• Prior experience within orthopedic or implantable medical device operations.
• Effective written and verbal communication skills.

Other:

• Language: English proficiency required.
• Travel: Limited travel may be required (generally less than 10%).
• Certifications: Qualityrelated certifications (e.g. ASQ) preferred but not required.

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