Job Description

Role Overview:

A growing life sciences manufacturer seeks a QMS leader to elevate quality systems and ensure compliance to medical device and life sciences regulations. Exciting growth opportunities in a dynamic environment!

Key Responsibilities:

Quality Systems Management:

• Manage training programs to ensure regulatory compliance.
• Oversee the internal audit program.
• Supervise supplier qualification processes.
• Support audits and inspections, including compliance with certifications such as ISO 9001.
• Administer document control processes, including periodic reviews, metadata management, and quality assessments.
• Maintain and manage the electronic quality management system.

Commissioning, Qualification, and Validation (CQV)/CSV:

• Review and approve CQV and CSV documentation.
• Maintain and oversee the validation schedule.

Operational Support:

• Provide on-site quality assurance support.
• Conduct log reviews, audit trail evaluations, and business continuity testing.
• Assist with quality events and change management.
• Support the onboarding of new sites.
• Provide general assistance to the quality function and leadership team.

Qualifications:

Required:

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 3-5 years of experience in quality assurance or quality systems management in a medical device environment.

Preferred:

• Familiarity with ISO 9001 and ISO 13485 standards.
• 3-5 years of experience in a GMP quality function.
• Knowledge of 21 CFR Part 11 and Part 211 compliance.
• Experience with internal and external audits.
• Understanding of validation processes (CQV/CSV) and supplier qualification procedures.

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